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Healthcare Field Reimbursement Manager - Northern CA at BridgeBio

Manages reimbursement access strategies, educates healthcare providers, and navigates authorization, affordability, and compliance processes for biopharma products.

Lead Posted 1 day ago RemoteFirstJobs Product
What this role involves

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries, and empower people to solve problems. If you’re someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we’ll ask ”why not?” and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Who You Are

As a Field Reimbursement Manager (Associate Director Level) at BridgeBio, you will work as an individual contributor, playing a crucial role in ensuring the community will have streamlined access to the company’s products, therapies, and services while navigating complex reimbursement processes. The position interacts with large, complex accounts to support community access within the aligned therapeutic area, proactively providing face-to-face education on access and affordability programs and community support services to providers and staff to support integration of those products into office processes and workflows. This position involves a combination of strategic thinking, expertise in reimbursement, and an understanding of healthcare regulations.

Responsibilities

  • Access Strategy: Develop and execute strategic plans for optimizing community access to the company’s products and therapies. This includes assessing access barriers, and proposing solutions for provider offices and institutions
  • Access Expertise: Serve as an in-house expert on authorization processes and requirements, collaborating with internal teams to navigate complex access challenges
  • Compliance: Ensure that all access and reimbursement activities adhere to healthcare regulations and compliance requirements, including healthcare laws and industry standards
  • Stakeholder Collaboration: Collaborate with healthcare provider offices, pharmacies, and other relevant stakeholders to address access issues, negotiate contracts (if needed), and streamline patient access pathways
  • Pharmacy Network Management: Evaluate, select, onboard and manage institutional pharmacies ensuring optimal access for appropriate community members
  • Data Analysis: Utilize data analysis and reporting tools to assess the efficiency and effectiveness of access and reimbursement processes, identifying areas for improvement and implementing necessary changes
  • Community Support Programs: manage and optimize community support programs, such as financial assistance initiatives, to help the community access and adhere to treatment
  • Policy and Market Analysis: Stay updated on changes in healthcare policy, market dynamics, and healthcare trends that may impact reimbursement and access, and adapt strategies accordingly

Education, Experience & Skills Requirements

  • Bachelor’s degree in a relevant field (Healthcare Administration, Business, etc…); Master’s degree or equivalent is a plus
  • Minimum of 5-8 years of Biotech/Pharma experience, including previous experience as an FRM
  • Rare disease experience is preferred
  • Ability to work independently and in a team environment
  • Experience in market access, community access or community services
  • In-depth knowledge of healthcare reimbursement processes, regulations, and compliance requirements
  • Excellent strategic thinking and problem-solving skills
  • Strong communication and interpersonal skills for effective collaboration with stakeholders
  • Proficiency in data analysis and reporting tools
  • Commitment to community-centered care and ensuring access to innovative treatments
  • Travel 60%

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Salary

$185,000—$230,000 USD

As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For BridgeBio Full-Time U.S Based Roles:

Financial & Rewards

  • Market-leading compensation

  • 401(k) with employer match

  • Employee Stock Purchase Program (ESPP)

  • Pre-tax commuter benefits (transit and parking)

  • Referral bonus for hired candidates

  • Subsidized lunch and parking on in-office days

Health & Well-Being

  • 100% employer-paid medical, dental, and vision premiums for you and your dependents

  • Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)

  • Fertility & family-forming benefits

  • Expanded mental health support (therapy and coaching resources)

  • Hybrid work model with flexibility

  • Flexible, “take-what-you-need” paid time off and company-paid holidays

  • Comprehensive paid medical and parental leave to care for yourself and your family

Skill Development & Career Paths:

  • People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

  • We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching

  • We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

By applying, you acknowledge that BridgeBio will process your personal information as described in ourGlobal Candidate Privacy Notice. Questions or requests:dataprivacy@bridgebio.com

Read the full description
Healthcare Associate Director, Clinical Operations at Telix Pharmaceuticals Limited

Leads global clinical trial planning and execution, overseeing compliance, budgets, vendors, timelines, recruitment, and clinical operations teams.

Lead Posted 7 days ago RemoteFirstJobs Product
What this role involves

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

Reporting to the Senior/ Director, Clinical Operations, the ADCO will ensure clinical stage programs meet objectives within timelines, budget, and quality standards. This involves operational planning and execution of clinical studies, ensuring compliance with GCP, ICH guidelines, regulatory requirements, and Telix’s SOPs. The ADCO will collaborate closely with teams in Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, and Program Management, as well as CROs, to execute studies on time and within budget. The ADCO is accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. The ADCO will also provide leadership and line management to their team, ensuring effective performance and development.

The ADCO will provide leadership in global subject/patient recruitment plans, communicate with key study PIs, oversee CRO/vendor management, and develop KPIs in collaboration with the clinical team. They will also create contingency/risk management plans and assist the Senior/ Director of Clinical Operations in development strategies. Additional duties include supporting clinical project managers, clinical trial assistants, interfacing with various departments, and providing variance analysis of budget to actual costs. The ADCO will lead the management and execution of all clinical trials with a clinical program. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met (depending on the program scope, the ADCO may still have direct trial management responsibilities).

Key Accountabilities:

•    Oversees the management of clinical trials from their inception to completion, expertly guiding both internal and external multidisciplinary teams

•    Leads and manages integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge

•    Manages performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving, highly experienced as a line manager

•    Drives the review and completion of all study-related plans and systems according to timelines and standards.

•    Effectively communicate and interact with study PIs, as required.

•    Manage and oversee aspects of CRO/vendor identification/procurement, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor, in collaboration with CPMs.

•    Participate in Case Report Form design, user acceptance testing in partnership with data management

•    Lead the development of contingency/risk management plans for projects and assist Sr Director/Director of Clinical Operations in the preparation and execution of sound development strategies

•    Provide support to clinical project managers within and/or across programs

•    Assist in preparing budgets, study timelines, and forecasts in collaboration with Sr. CPM/CPM  for Sr Director/Director of Clinical Operations approval

•    Maintain rigorous compliance with study plans, monitoring clinical studies through direct communication with CROs and investigator sites

•    Strategically plan and coordinate with cross-functional teams for optimal execution of clinical trials

•    Identify potential study issues, formulating proactive contingency plans

•    Mentor team members and manage direct reports, fostering professional growth

•    Participates in the development and review of the protocol and informed consent to provides an operational feasibility perspective and confirm clarity of procedures

  • Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department.
  • Oversees study budget, investigator and vendor contracts, budgets, and payments, reviews accruals on a regular basis.
  • Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready.
  • Supports audit/inspection activities as needed.
  • Maintain a state of inspection readiness for clinical development inclusive of TMF.
  • Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
  • Initiate clinical change control process for studies, as appropriate
  • Embrace an organizational culture that fosters diversity, equity, and inclusion
  • Perform additional duties as required by the evolving needs of the organization

Key Capabilities:

  • Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
  • Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
  • Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

Read the full description
Healthcare Associate Director, Clinical Operations at Telix Pharmaceuticals Limited

Leads global clinical trial planning and execution, overseeing CROs, budgets, timelines, compliance, recruitment, and clinical operations teams.

Lead Posted 7 days ago RemoteFirstJobs Product
What this role involves

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

Reporting to the Senior/ Director, Clinical Operations, the ADCO will ensure clinical stage programs meet objectives within timelines, budget, and quality standards. This involves operational planning and execution of clinical studies, ensuring compliance with GCP, ICH guidelines, regulatory requirements, and Telix’s SOPs. The ADCO will collaborate closely with teams in Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, and Program Management, as well as CROs, to execute studies on time and within budget. The ADCO is accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. The ADCO will also provide leadership and line management to their team, ensuring effective performance and development.

The ADCO will provide leadership in global subject/patient recruitment plans, communicate with key study PIs, oversee CRO/vendor management, and develop KPIs in collaboration with the clinical team. They will also create contingency/risk management plans and assist the Senior/ Director of Clinical Operations in development strategies. Additional duties include supporting clinical project managers, clinical trial assistants, interfacing with various departments, and providing variance analysis of budget to actual costs. The ADCO will lead the management and execution of all clinical trials with a clinical program. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met (depending on the program scope, the ADCO may still have direct trial management responsibilities).

Key Accountabilities:

•    Oversees the management of clinical trials from their inception to completion, expertly guiding both internal and external multidisciplinary teams

•    Leads and manages integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge

•    Manages performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving, highly experienced as a line manager

•    Drives the review and completion of all study-related plans and systems according to timelines and standards.

•    Effectively communicate and interact with study PIs, as required.

•    Manage and oversee aspects of CRO/vendor identification/procurement, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor, in collaboration with CPMs.

•    Participate in Case Report Form design, user acceptance testing in partnership with data management

•    Lead the development of contingency/risk management plans for projects and assist Sr Director/Director of Clinical Operations in the preparation and execution of sound development strategies

•    Provide support to clinical project managers within and/or across programs

•    Assist in preparing budgets, study timelines, and forecasts in collaboration with Sr. CPM/CPM  for Sr Director/Director of Clinical Operations approval

•    Maintain rigorous compliance with study plans, monitoring clinical studies through direct communication with CROs and investigator sites

•    Strategically plan and coordinate with cross-functional teams for optimal execution of clinical trials

•    Identify potential study issues, formulating proactive contingency plans

•    Mentor team members and manage direct reports, fostering professional growth

•    Participates in the development and review of the protocol and informed consent to provides an operational feasibility perspective and confirm clarity of procedures

  • Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department.
  • Oversees study budget, investigator and vendor contracts, budgets, and payments, reviews accruals on a regular basis.
  • Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready.
  • Supports audit/inspection activities as needed.
  • Maintain a state of inspection readiness for clinical development inclusive of TMF.
  • Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
  • Initiate clinical change control process for studies, as appropriate
  • Embrace an organizational culture that fosters diversity, equity, and inclusion
  • Perform additional duties as required by the evolving needs of the organization

Key Capabilities:

  • Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
  • Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
  • Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

Read the full description
Healthcare Health Coach Manager

Manages health coaches delivering personalized guidance and coordinating support for clients' wellness goals.

Lead Posted 8 days ago Jobicy AI
What this role involves
About Us: Future is building a personalized guidance system for lifelong health. We help people understand what to do next for their body, goals, and stage of life — then...
Read the full description
Healthcare Quality Assurance, CQV lead at Telix Pharmaceuticals Limited

Leads quality assurance oversight for pharmaceutical facility commissioning, qualification, validation, compliance, and operational readiness across manufacturing sites.

Lead Onsite Posted 8 days ago RemoteFirstJobs Product
What this role involves

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Quality Assurance Commissioning, Qualification, and Validation (CQV) Lead is a highly mobile, site-based role requiring extensive travel across the Telix Manufacturing Solution (TMS) network in the United States. Reporting to the Quality Director, Manufacturing Expansion & Readiness, the role provides Quality Assurance support and oversight for facility construction and expansion, equipment and utility qualification, computerized systems validation, process validation, and operational readiness.

Travel is expected to exceed 75% and may require extended stays of several weeks at a site, depending on project schedules, validation timelines, and readiness milestones. The role partners with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs to ensure CQV activities meet applicable cGMP requirements and Telix Quality Systems.

The position will support the implementation of quality oversight, validation strategies, risk management practices, documentation, and inspection-readiness activities needed to transition sites from project execution to routine GMP operations and support clinical and commercial manufacturing.

Key Accountabilities:

CQV & Quality Oversight

Provide Quality Assurance oversight for CQV and operational readiness activities across the TMS network.

  • Review and approve validation lifecycle documentation, including VMPs, risk assessments, protocols, reports, and qualification
  • Ensure facility startup, expansion, and remediation activities comply with applicable cGMP requirements, including 21 CFR Parts 210, 211, and 212, as relevant to the site.
  • Apply risk-based approaches to commissioning, qualification, and validation

Quality Systems & Compliance

Support the implementation of quality systems, procedures, and governance needed to transition facilities into routine GMP operations.

  • Review and approve deviations, investigations, CAPAs, change controls, and quality risk assessments related to CQV Contribute to consistency and compliance of qualification and validation practices at assigned sites.
  • Promote data integrity, quality culture, and GMP compliance throughout project execution and routine

Project Readiness & Collaboration

  • Partner with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs to support project execution and GMP readiness.
  • Monitor project milestones, validation deliverables, and site-readiness metrics; escalate compliance risks and execution
  • Support technology transfers, manufacturing readiness, site activation, and the handoff to on-site Quality Assurance and Quality Control teams.

Contractor & On-Site Support

Lead readiness activities for regulatory inspections and internal or customer audits related to facility startup and validation. Coordinate and monitor contractors, validation consultants, engineering firms, and service providers supporting CQV activities

Education and Experience:

  • Bachelor’s degree required. Orientation in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences, or a related scientific discipline. Advanced degree is desirable.,
  • 5 years of experience in Quality Assurance, Validation, Engineering Quality, or CQV within the pharmaceutical, biotechnology or radiopharmaceutical industry.
  • Minimum 5 years of direct experience supporting Commissioning, Qualification, and Validation (CQV) activities for GMP facilities and manufacturing systems.
  • Experience reviewing and approving Validation Master Plans (VMPs), User Requirement Specifications (URS), Design Qualification (DQ), IQ/OQ/PQ protocols, risk assessments, and validation reports.
  • Technical understanding of manufacturing, quality and regulatory requirements,
  • Previous experience writing and reviewing with understanding SOPs,
  • Willingness and ability to travel more than 75% across multiple S. manufacturing sites, including extended stays of several weeks, based on project schedules and validation timelines.
  • Languages: English

Key Capabilities:

  • Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
  • Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
  • Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

Read the full description
Healthcare Quality Assurance, CQV lead at Telix Pharmaceuticals Limited

Leads quality assurance oversight for pharmaceutical facility commissioning, qualification, validation, GMP compliance, and operational readiness across manufacturing sites.

Lead Onsite Posted 8 days ago RemoteFirstJobs Product
What this role involves

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Quality Assurance Commissioning, Qualification, and Validation (CQV) Lead is a highly mobile, site-based role requiring extensive travel across the Telix Manufacturing Solution (TMS) network in the United States. Reporting to the Quality Director, Manufacturing Expansion & Readiness, the role provides Quality Assurance support and oversight for facility construction and expansion, equipment and utility qualification, computerized systems validation, process validation, and operational readiness.

Travel is expected to exceed 75% and may require extended stays of several weeks at a site, depending on project schedules, validation timelines, and readiness milestones. The role partners with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs to ensure CQV activities meet applicable cGMP requirements and Telix Quality Systems.

The position will support the implementation of quality oversight, validation strategies, risk management practices, documentation, and inspection-readiness activities needed to transition sites from project execution to routine GMP operations and support clinical and commercial manufacturing.

Key Accountabilities:

CQV & Quality Oversight

Provide Quality Assurance oversight for CQV and operational readiness activities across the TMS network.

  • Review and approve validation lifecycle documentation, including VMPs, risk assessments, protocols, reports, and qualification
  • Ensure facility startup, expansion, and remediation activities comply with applicable cGMP requirements, including 21 CFR Parts 210, 211, and 212, as relevant to the site.
  • Apply risk-based approaches to commissioning, qualification, and validation

Quality Systems & Compliance

Support the implementation of quality systems, procedures, and governance needed to transition facilities into routine GMP operations.

  • Review and approve deviations, investigations, CAPAs, change controls, and quality risk assessments related to CQV Contribute to consistency and compliance of qualification and validation practices at assigned sites.
  • Promote data integrity, quality culture, and GMP compliance throughout project execution and routine

Project Readiness & Collaboration

  • Partner with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs to support project execution and GMP readiness.
  • Monitor project milestones, validation deliverables, and site-readiness metrics; escalate compliance risks and execution
  • Support technology transfers, manufacturing readiness, site activation, and the handoff to on-site Quality Assurance and Quality Control teams.

Contractor & On-Site Support

Lead readiness activities for regulatory inspections and internal or customer audits related to facility startup and validation. Coordinate and monitor contractors, validation consultants, engineering firms, and service providers supporting CQV activities

Education and Experience:

  • Bachelor’s degree required. Orientation in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences, or a related scientific discipline. Advanced degree is desirable.,
  • 5 years of experience in Quality Assurance, Validation, Engineering Quality, or CQV within the pharmaceutical, biotechnology or radiopharmaceutical industry.
  • Minimum 5 years of direct experience supporting Commissioning, Qualification, and Validation (CQV) activities for GMP facilities and manufacturing systems.
  • Experience reviewing and approving Validation Master Plans (VMPs), User Requirement Specifications (URS), Design Qualification (DQ), IQ/OQ/PQ protocols, risk assessments, and validation reports.
  • Technical understanding of manufacturing, quality and regulatory requirements,
  • Previous experience writing and reviewing with understanding SOPs,
  • Willingness and ability to travel more than 75% across multiple S. manufacturing sites, including extended stays of several weeks, based on project schedules and validation timelines.
  • Languages: English

Key Capabilities:

  • Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
  • Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
  • Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

Read the full description
Healthcare Quality Control, Validation Lead at Telix Pharmaceuticals Limited

Leads pharmaceutical QC laboratory startup, analytical method validation, equipment qualification, compliance documentation, and inspection readiness across manufacturing sites.

Lead Onsite Posted 8 days ago RemoteFirstJobs Product
What this role involves

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Quality Control Validation Lead supports the startup and readiness of Quality Control laboratories across the Telix Manufacturing Solution (TMS) network, providing technical and quality oversight for laboratory commissioning, qualification, validation, analytical methods, equipment, systems, and testing processes supporting clinical and commercial manufacturing. The lead partners with site Quality Control, Manufacturing, Technical Operations, Validation, Regulatory, and external laboratories to establish compliant QC operations, transfer and validate methods, qualify equipment, support regulatory submissions, and maintain inspection readiness.

This is a highly mobile, on-site role requiring more than 75% travel across multiple U.S. manufacturing sites, including stays of several weeks at a site. Travel will be driven by site startup, qualification, validation, method transfer, and operational readiness timelines.

Key Accountabilities:

Laboratory Startup & Readiness

  • Support QC laboratory startup, qualification, validation, and operational readiness across TMS
  • Coordinate equipment calibration, maintenance, qualification, and lifecycle
  • Establish GMP-compliant laboratory systems, procedures, documentation, and data integrity
  • Transition validated laboratories to on-site QC

Methods, Testing & Stability

  • Lead analytical method development, transfer, verification, and validation for clinical and commercial
  • Support technology transfers for new products, processes, and analytical
  • Coordinate internal and contract laboratory
  • Develop and maintain stability programs, protocols, and

Documentation, Compliance & Inspections

  • Author and maintain analytical methods, specifications, protocols, reports, and QC
  • Review analytical data, validation results, deviations, OOS/OOT investigations, CAPAs, and change
  • Lead root cause analysis for analytical failures, atypical results, and quality
  • Maintain readiness for regulatory inspections and internal or customer
  • Support analytical content for regulatory submissions and health authority responses, as

Network Support & Travel

  • Standardize and improve QC practices, analytical procedures, and validation approaches across the TMS

Travel more than 75% to provide on-site support for startup, qualification, validation, and commercial readiness.

Education and Experience:

  • Bachelor’s degree required in Chemistry, Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, Microbiology, Radiochemistry, or related scientific discipline. Advanced degree preferred.
  • Strong knowledge of FDA, ICH, USP, and applicable regulatory requirements governing Quality Control laboratories and analytical testing 21FR 211, 212.
  • Development, Validation, or GMP laboratory operations within the pharmaceutical, biotechnology or radiopharmaceutical industry.
  • Demonstrated experience in analytical method development, method validation, method transfer, and analytical lifecycle
  • Experience supporting laboratory investigations, OOS/OOT events, deviations, CAPAs, change controls, and regulatory inspections within a GMP environment.
  • Experience authoring, reviewing, and approving analytical methods, specifications, validation protocols, reports, investigations, and GMP laboratory documentation.
  • Willingness and ability to travel extensively (>75%) across multiple US manufacturing sites based on project schedules and validation timelines, including staying for several weeks on the site.
  • Languages: English

Key Capabilities:

  • Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
  • Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
  • Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

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Healthcare Director, Medical Affairs at Click Therapeutics, Inc.

Leads medical affairs strategy, scientific evidence development, medical communications, expert engagement, and governance for digital therapeutics.

Lead Posted 11 days ago RemoteFirstJobs Product
What this role involves

Who We Are:

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.

About the Role:

As Director of Medical Affairs, you are a senior scientific leader within Click Therapeutics’ Medical Affairs organization, working across our portfolio. Reporting to the Vice President of Medical Affairs, you own the scientific evidence and the scientific relationships that establish our treatments with clinicians, payers and the wider medical community: what the evidence says, what it means clinically and economically, where the gaps are, and how it reaches the people who make treatment and coverage decisions.

You will build the medical strategy and tactics that inform clinical and payer decision-making, develop the evidence strategy and medical materials needed, and engage the experts and institutions that shape how a new therapeutic category is understood. You will direct the agencies, CROs and vendors that execute it, and establish the Medical Information, medical review and Medical Affairs governance that scale with the portfolio.

If you have an entrepreneurial spirit, a strategic mind, and a strong record of building medical value stories, evidence plans and scientific relationships in a regulated environment, you are the right candidate. This is an agile position within a rapidly growing pre-IPO company in a nascent and fast-growing space.

This position is based out of Click’s headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities or remote. We have a hybrid working model that consists of at least 4 days in office each week.

Responsibilities:

Medical Strategy & Evidence

  • Define the medical strategy for each asset, including the target patient profile, clinical place in therapy, and the priorities that guide evidence generation and scientific engagement.
  • Establish the clinical meaningfulness of trial endpoints and outcome measures, and monitor the clinical and competitive landscape to identify emerging tactics, arguments and gaps in our data packages.
  • Own the evidence plan to address the evidence needs of clinicians and payers, and drive its execution.

Scientific Communications

  • Develop and maintain the Core Medical Narrative for each asset, and build the field medical materials, medical value story decks and payer-facing scientific content, including the clinical sections of Value Dossiers and evidence packages with Market Access.
  • Own the publication and congress plan, managing medical communications agencies and writers as the scientific reviewer accountable for accuracy and balance.
  • Establish and own Medical Information to support timely, accurate and balanced responses to unsolicited requests from HCPs.

External Engagement

  • Own the engagement strategy for each asset: identify, segment and prioritize the national and regional experts, institutions and payer clinical decision-makers.
  • Lead compliant peer-to-peer scientific exchange with clinical experts, health systems, advocacy organizations and payer medical leadership, and direct our scientific presence at major congresses and advisory boards.
  • Drive and synthesize field insight into recommendations that shape medical strategy, scientific content and evidence priorities.

Qualifications:

At Click, we aren’t just looking for talent; we are looking for the next evolution of the modern professional. To us, AI is not a future possibility, it is a present-day prerequisite. We expect every Click colleague to have seamlessly integrated AI into their professional workflow and personal productivity, using it as a force multiplier to move faster, think deeper, and deliver superlative results that were previously out of reach. If you do not yet view AI as an essential partner in your daily pursuit of excellence, you will find it impossible to keep pace with our mission. High performers who harness AI technology to transcend traditional boundaries and set new benchmarks for professional excellence will thrive at Click.

  • Education & Experience
    • Advanced degree required (MD, DO, PhD or PharmD).
    • 10+ years of combined industry, academic, clinical research, or other clinical practice experience, of which at least 5 years in the pharmaceutical industry, including experience supporting a product launch.
    • Demonstrated experience building medical value stories, scientific narratives and medical response content that hold up with clinicians, payers and regulators.
    • Experience planning and executing evidence and publication strategy, including study design, protocol development and CRO, agency and vendor management.
    • Prior field-based experience, such as an MSL role, with a track record of building peer-to-peer scientific relationships with clinical experts and payer decision-makers and translating those conversations into medical impact.
    • Strong analytical judgment: able to interpret trial statistics and outcome measures; critically assess evidence strengths and gaps; and communicate complex data clearly.

Click Preferred Qualifications:

  • Knowledge of or experience with Digital Therapeutics and/or Prescription Digital Therapeutics is considered a plus.

  • Experience establishing Medical Affairs infrastructure in an early-stage or pre-commercial organization.

Compensation:

The base salary range for this position is between $175,000 - $220,000. The final base salary will be dependent upon skills, experience and location. In addition to the base salary, Click Therapeutics offers an annual performance-based cash bonus and a generous equity package.

Benefits:

The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space.

Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5% 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fitness Reimbursement | Bike Membership | Professional Development Stipend | DoorDash | Parent Benefits | LinkedIn Learning | Gemini Enterprise Stack | Claude | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Sponsored Company Events | Office Snacks and Beverages | Much More…

Equal Employment Opportunity:

Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague’s long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague’s temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the “at-will” employment relationship between the colleague and Click Therapeutics.

Recruitment Phishing Scams:

Fake job advertisements and offers are increasingly appearing on the internet. If you have encountered a job posting or have been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond and report it to the Federal Trade Commission and the FBI at https://www.ic3.gov/Home/ComplaintChoice.

Please be mindful of the following:

  • Click Therapeutics will only reach out to you through an “@clicktherapeutics.com” email address.Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver’s License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams).
  • Click Therapeutics will conduct interviews face-to-face over Zoom.
  • All job postings will be listed on the Click Therapeutics official career page.
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Healthcare Supervisor, MLS Data Review at Natera

Supervises laboratory staff, schedules sample processing, ensures quality and regulatory compliance, handles errors, and supports training and performance management.

Lead Posted 12 days ago RemoteFirstJobs Product
What this role involves

POSITION SUMMARY:

Works closely with manager to ensure company and team goals are met. Ensures high quality work is completed timely.

PRIMARY RESPONSIBILITIES:

• Responsible for day-to-day staffing/scheduling/setting up sample run schedules.

• Ensures production work is consistently completed according to department goals.

• Ensures all case samples are processed and accounted for.

• High proficiency working within one or more laboratory information systems to ensure all relevant data is correct.

• Monitors cases reaching promised TAT and identify issue/cause/reason for those cases. Work with managers and other departments as needed to prevent future incident.

• Updates SOPs to accurately reflect current practices and works with manager and Document  Control/QA/Training team to make effective.

• Monitors team members to ensure adherence to SOPs and safety procedures

• Oversees training for new hires: works in conjunction with lead to train new hires.

• Investigates/follows up on lab errors (NCR).

• Assists manager in initiating and completing CAPAS.

• Handles employee issues. Collaborates with Manager to resolve issues.

• Ensures alignment with team for reasoning behind instructions/processes, changes that are made, why certain ideas cannot be implemented effectively.

• Meets regularly with individual team members to discuss goals and progress.

• Responsible for staff performance reviews.

• Plans and leads shift meetings

• Adheres to Departmental Expectations

• Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action.

• Go-to person when manager is not present.

• May assist lab team in day to day tasks

• Keeps team morale up and maintains professionalism of team members, including by acting as role model.

• Approves timecards and PTO requests

• Escalates lab issues and team concerns to manager. Communicates the problem and suggests possible solutions.

• Understands the entire lab process and is able to identify and troubleshoot issues when they arise.

• Understands when and how to escalate issues appropriately.

• Makes sure the goals set by manager for the team are being met in the lab.

• Performs and completes side projects assigned by the manager.

• Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support.

• Receives assignments in the form of objectives with goals and the process by which to meet goals.

• Provides direction to employees according to established policies and management guidance.

• Administers company policies that directly affect subordinate employees.

• Provides direct supervision to professional individual contributors and/or skilled, support individual contributors

• Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.

• This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job

• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

• Must maintain a current status on Natera training requirements.

• Employee must pass post offer criminal background check.

• Performs other duties as assigned.

QUALIFICATIONS:

• 6+ years of experience as a Medical Technologist or equivalent in a clinical laboratory environment.

• BS/BA degree in Biological Sciences, related field, or equivalent

• Current ASCP board certification in Medical Technology or California State CLS or CGMBS license (Clinical Genetics Molecular Biologist Scientist).

KNOWLEDGE, SKILLS, AND ABILITIES:

• Proven leadership experience

• Able to take on own projects with little supervision.

• Excellent interpersonal, communication, computer, troubleshooting, and pipetting skills.

• Excellent oral and written communication skills.

• Word processing and data management skills.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Duties typically performed in office setting

• Standing or sitting for long periods of time may be necessary

• Duties may require working weekends

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:

- BBB announcement on job scams

- FBI Cyber Crime resource page

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Healthcare Clinical Strategy and Program Development Lead

Leads clinical strategy and program development, shaping enterprise clinical performance measurement and improvement initiatives.

Lead Posted 13 days ago Himalayas
What this role involves
Become a part of our caring community The Clinical Performance Strategy & Measurement Team shapes how Humana defines, measures, and improves clinical performance across the enterprise.
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Healthcare Associate Manager, Pharmacovigilance| Post-Marketing Case Processing| Hybrid, Bangalore at MMS

Leads post-marketing pharmacovigilance case processing, regulatory compliance, safety reporting, client coordination, and team mentorship.

Lead Hybrid Posted 13 days ago RemoteFirstJobs Product
What this role involves

Are you looking to join a company where your contributions truly matter, and where you’ll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Please Note: The final title for this position will be determined based on the successful candidate’s experience, background, and qualifications.

Roles and Responsibilities:

  • Lead and oversee global post-marketing case processing activities from intake through reporting and case closure.
  • Develop and maintain pharmacovigilance workflows, procedures, and work instructions as related to post marketing case processing.
  • Ensure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPs.
  • Proficient in ICH E2A, E2B(R3), and E2D guidelines
  • Proficient in Pharmacovigilance quality systems
  • Maintains an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing. Understands clinical trial processes.
  • Independent Project lead, SME; provides strategic narrative development internally and externally, directly negotiates with client.
  • Process cases independently, understands steps involved with case processing. Leads creation/updates of high-quality deliverables.
  • Extensive experience working within a safety database and directly interacts with clients. Expert knowledge of coding with MedDRA and WHO drug dictionary.
  • Proficient in understanding impact of updates in related deliverables
  • Independently managing/leading client meetings and CRMs for effective resolutions; provides mentorship to others.
  • Proficient with managing a project from start to finish and compliant with process; provides mentorship to others; identifies efficiencies within department processes.

Requirements:

  • College graduate in scientific, medical, clinical discipline or related field, or related experience, masters, PharmD, or PhD preferred.
  • Minimum of 7 years’ experience in drug safety, pharmacovigilance, or similar field required.
  • Expert knowledge of scientific principles and concepts.
  • Expertise in using drug safety databases.
  • Own and drive end-to-end process development, implementation and continuous improvement
  • Reputation as emerging leader in field with sustained performance and accomplishment.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred.
  • Good communication skills and willingness to work with others to clearly understand needs and solve problems.
  • Excellent problem-solving skills.
  • Good organizational and communication skills.
  • Familiarity with current ISO 9001 and ISO 27001 standards preferred.
  • Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
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Healthcare Head of Psychiatric Practice

Leads psychiatric practice operations and oversees mental health care delivery for individuals, families, and communities.

Lead Posted 14 days ago Himalayas
What this role involves
At LifeStance Health, we strive to help individuals, families, and communities with their mental health needs.
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Healthcare Registered Nurse Team Lead at Twin Health

Leads registered nurses while providing clinical guidance, health education, behavior-change support, and care coordination for members managing metabolic conditions.

Lead Posted 15 days ago RemoteFirstJobs Product
What this role involves

Twin Health

At Twin Health, we empower people to improve and prevent chronic metabolic diseases, like type 2 diabetes and obesity, with a new standard of care. Twin Health is the only company applying AI Digital Twin technology exclusively toward metabolic health.

We start by building a dynamic model of each person’s metabolism — drawing on thousands of data points from CGMs, smartwatches, and meal logs — that maps their personal path to better health. Guided by a dedicated clinical care team, our members have lowered their A1C below the diabetes range, achieved lasting weight loss, and reduced or even eliminated medications, all while living healthier, happier lives.

Working here

Our team at Twin Health is passionate, talented, and united by a shared purpose: to improve the metabolic health and happiness of our members. We believe in empowering every Twin to make a meaningful impact for our members, our clients, and each other, while enjoying a supportive, collaborative work environment.

Twin has been recognized not only for our innovation but also for our culture, including: Innovator of the Year by the Employer Health Innovation Roundtable (EHIR), selected to CB Insights’ Digital Health 150, and named one of Newsweek’s Top Most Loved Workplace® .

With more than $100 million raised in recent funding, including a $53 million Series E round in 2025 led by Maj Invest, and a $50 million investment in 2023 led by Temasek, Twin is scaling rapidly across the U.S. and globally. Backed by leading venture firms like ICONIQ Growth, Sequoia, Sofina, Temasek, and Peak XV, we are building the most impactful digital health company in the world.

Join us as we reinvent the standard of care in metabolic health.

Opportunity

Join us in one of our most critical clinician roles, inspiring behavior change and motivating members to adopt new behaviors and improve their health. As an RN at Twin you make a difference in people’s lives every day by providing clinical guidance, support, education, and encouragement to empower your members seeking to prevent and reverse chronic metabolic diseases and improve their overall health.

The RN Team Lead role is a great fit for you if you have experience managing operational initiatives, driving or supervising teams and their work, delivering on results and building rapport with departmental partners. You are also highly motivated, energetic, and focused on  enhancing the quality of healthcare. You have demonstrated the ability to work collaboratively with an interdisciplinary care team in the adoption of new technologies to coordinate care, engage in shared decision making, and achieve successful clinical outcomes. You are comfortable leveraging data in observing trends and developing corrective action plans to facilitate the transformation of member lives.

Join Us                                                                                                                                                                        This is an exciting role for a Registered Nurse with a diverse healthcare systems background. Join us to use your finely-tuned skills providing patient care and overseeing team successes in accomplishing outcomes. You will also support a dynamic care team in identifying member goals, health priorities and learning opportunities. This will include acting independently to determine methods and procedures on new or special assignments, collaborating with partners and teams, while leading and overseeing direct reports. Other skill set considerations include ability to work efficiently and with competing priorities, comfort with technology and data, as well as employing knowledge of care management principles.

This role will report to nurse management and work within a team structure. A successful candidate for this role will be curious, collaborative and adaptable to member journey and team needs. You will be excited to jump into a day that may look a bit different than the day before, while making improvements along the way and building upon your highly-valued skill set.

Responsibilities

  • Responsible for daily operations of direct reports while providing limited, clinical care duties
  • Addresses clinical and administrative concerns such as troubleshooting and issue resolution, ensuring staff coverage and gathering feedback on care delivery systems to ensure safety, compliance, accuracy and standardization
  • Achieves and upholds Twin service care goals, standards of clinical practice and outcomes, which includes monitoring and managing team performance, meeting SLAs and targets
  • Guides development, organization and communication of nursing/team policies and procedures
  • Supports recruitment, training and mentoring of a US-based team
  • Manages achievement of KPI goals for team and Twin Service outcomes
  • Aligns and collaborates with cross-functional team leads, and serves as team representative and/or subject matter expert on initiatives and projects
  • Works with teams to collect data, insights and front-line feedback to help inform decisions
  • Promotes member self-care management by utilizing clinical judgment, data analysis and critical thinking skills
  • Prioritizes and manages individual members along the Twin journey by monitoring health condition reversal trends, conducting lab reviews, supporting medication management
  • Collaborates closely with team colleagues including nurses, health coaches, providers, and operations teams to drive a seamless experience for members
  • Provides timely responses and feedback to colleagues regarding member care, escalations and issue resolution
  • Organizes accurate records and maintains confidentiality according to federal law and Twin policies
  • Generates and analyzes reports as needed for management, identifying trends, anomalies and areas of concerns
  • Participates in on-going education and performance improvement activities
  • Additional duties as assigned

Qualifications

  • Currently active and unencumbered RN license
  • Minimum 5 years of direct patient care nursing experience, including 3 years in leadership role (i.e. unit or clinic supervisor, charge nurse, preceptor, other management area).
  • Required, BSN from accredited school of nursing
  • Comfort and enthusiasm for adopting the latest technologies and integrating data and technical outputs in patient care
  • Demonstrated ability to manage large caseloads and effectively work in a fast paced environment
  • Proficient with simultaneously navigating the internet and multi-tasking with multiple electronic documentation systems and business tools (Google, Slack, etc.)
  • Comfort with ambiguity and change
  • Self-motivated and results-focused
  • Quick learner who integrates new knowledge
  • Organized and detail-oriented
  • Ability to handle competing demands with diplomacy and enthusiasm
  • Ability to work collaboratively with clinical infrastructure and hierarchies
  • Excellent time management and ability to prioritize work assignments
  • Passion for Twin’s purpose to transform lives by empowering people to reverse, prevent and improve chronic metabolic diseases

Compensation and Benefits

The compensation range for this position is $90,000-$112,000 annually.

Twin has an ambitious vision to empower people to live healthier and happier lives, and to achieve this purpose, we need the very best people to enhance our cutting-edge technology and medical science, deliver the best possible care, and turn our passion into value for our members, partners and investors. We are committed to delivering an outstanding culture and experience for every Twin employee through a company based on the values of passion, talent, and trust. We offer comprehensive benefits and perks in line with these principles, as well as a high level of flexibility for every Twin

  • A competitive compensation package in line with leading technology companies
  • A remote and accomplished global team
  • Opportunity for equity participation
  • Unlimited vacation with manager approval
  • 16 weeks of 100% paid parental leave for delivering parents; 8 weeks of 100% paid parental leave for non-delivering parents
  • 100% Employer sponsored healthcare, dental, and vision for you, and 80% coverage for your family; Health Savings Account and Flexible Spending Account options
  • 401k retirement savings plan

Salary range for US jobs

US Salary Range

$90,000—$110,000 USD

We have been made aware of fraudulent interview requests being sent using the Twin Health’s name. All communications will come from official Twin Health channels and a twinhealth.com email address. We will never ask you to complete a text interview or request financial details during the interview process.

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Healthcare Clinical Hub Supervisor

Supervises clinical hub operations and coordinates pharmacy-related clinical support for long-term care healthcare organizations.

Lead Posted 17 days ago Himalayas
What this role involves
Our CompanyPharMericaOverviewPharMerica, a part of Brightspring Health Services, is a long‑term care pharmacy services provider that supplies medications, clinical support, and pharmacy management to healthcare organizations across the United States.
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Healthcare Clinical Laboratory Supervisor at Natera

Supervises clinical laboratory staff, schedules testing operations, ensures SOP and regulatory compliance, and manages training, quality issues, and corrective actions.

Lead Onsite Posted 19 days ago RemoteFirstJobs Product
What this role involves

Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company)

Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer.

We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us.

Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day.

About The Role

The Clinical Lab Supervisor is a leader in Natera’s lab operations whose role is to oversee employees’ performance and serve as a liaison between employees and senior management to meet company goals and quality objectives. The supervisor is responsible for daily supervision of lab staff performing duties such as laboratory testing and data review. Duties include but are not limited to coaching, motivating, staffing, evaluating, and training staff. The supervisor works closely with the manager to ensure company and team goals are met while adhering to good manufacturing practices and CLIA/CAP guidelines.

What You Will Do

  • Responsible for day-to-day staffing/scheduling/setting up sample run schedules.
  • Ensures production work is consistently completed according to department goals.
  • Ensures all case samples are processed and accounted for.
  • Monitors team members to ensure adherence to SOPs and safety procedures.
  • Oversees training for new hires: works in conjunction with lead to train new hires.
  • Document nonconformance reports and all corrective actions taken when test systems deviate from the established performance specifications as needed. Escalates protocol deviation to lead/supervisor.
  • Handles employee issues. Collaborates with Manager and/or Human Resources to resolve issues.
  • Assists manager in initiating and completing CAPAs.
  • Ensures alignment with team for reasoning behind instructions/processes and changes.
  • Meets regularly with individual team members to discuss goals and progress.
  • Responsible for staff performance reviews.
  • Plans and leads shift meetings.
  • Maintains team morale and professionalism of team members, including by acting as role model. Adheres to Departmental Expectations.
  • Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action. Go-to person when manager is not present.
  • May assist lab team in day to day tasks.
  • Keeps team morale up and maintains professionalism of team members, including by acting as role model.
  • Assists the team in day to day lab work if necessary.
  • Approves timecards and PTO requests.
  • Escalates lab issues and team concerns to manager. Communicates the problem and suggests possible solutions.
  • Understands the entire lab process and can identify and troubleshoot issues when they arise. Understands when and how to escalate issues appropriately.
  • Makes sure the goals set by manager for the team are being met in the lab.
  • Performs and completes side projects assigned by the manager.
  • Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support.
  • Receives assignments in the form of objectives with goals and the process by which to meet goals.
  • Provides direction to employees according to established policies and management guidance. Administers company policies that directly affect subordinate employees.
  • Recommends changes to unit or sub-unit policies.
  • Provides direct supervision to professional individual contributors and/or skilled, support individual contributors.
  • Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
  • This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job.
  • Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
  • Must maintain a current status on Natera training requirements.
  • Employee must pass post offer criminal background check.
  • Performs other duties as assigned.

What You Will Bring

  • 6+ years of experience as a Medical Technologist or equivalent in a clinical laboratory environment.
  • BS/BA degree (or equivalent) in Medical Technology, Biological Sciences, or a related field.
  • Current MT/MLS/CLS certification preferable from ASCP, AMT, or AAB.
  • Proven leadership experience.
  • Able to take on projects with little supervision.
  • Excellent interpersonal, communication, computer, troubleshooting, and pipetting skills.
  • Experience in Molecular Biology.
  • Excellent oral and written communication skills.
  • Word processing and data management skills.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

  • Duties typically performed in BSL-1 to 2 laboratories with potentially hazardous material Standing or sitting for long periods of time may be necessary
  • Duties may require working weekends and overtime
  • Must be able to lift boxes or supplies up to 35lbs
  • Duties require wearing safety goggles, gloves, and laboratory coat.
  • Duties may require exposure to cold air due to frequent accessing of refrigeration and/or freezer units.

Compensation & Total Rewards

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:

  • Annual performance incentive bonus
  • Long-term equity awards
  • Comprehensive health benefits (medical, dental, vision)
  • 401(k) with company match
  • Generous paid time off and company holidays
  • Additional wellness and work-life benefits

Compensation Range

$91,100.00 - $100,000.00

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:

- BBB announcement on job scams

- FBI Cyber Crime resource page

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