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Director, Clinical Pharmacology

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Moderna

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Location:
United States , Cambridge

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Category:
IT - Software Development

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Contract Type:
Employment contract

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Salary:

167000.00 - 300700.00 USD / Year
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Job Description:

The role is positioned in the Clinical Pharmacology group, Clinical and Quantitative Pharmacology (CQP) function. This individual will bring strong technical and strategic expertise in clinical pharmacology, Model-Informed Drug Development (MIDD), representing CQP on program teams, and contributing significantly to advancing our exciting mRNA platform and therapeutic pipeline. This role will closely partner with CQP colleagues in Pharmacometrics and Quantitative Systems Pharmacology to determine and implement the overall CQP strategies across therapeutic areas, from preclinical development through lifecycle management. Success in this role requires close collaboration with Translational Medicine, Research (including Nonclinical Development), Clinical Development, Clinical Safety and Risk Management, Biometrics, and Regulatory functions to ensure integrated and innovative clinical pharmacology strategies are developed and executed to enable agile development of our exciting pipeline.

Job Responsibility:

  • Develop a fit-for-purpose Clinical Pharmacology development plan, including dose selection and optimization, evaluation plan for special populations, PK/PD and immunogenicity assessment, and pediatric development
  • Collaborate with program teams to develop dose selection strategy and support decision makings for first-in-human studies and IND submissions
  • Represent CQP in a highly matrixed team setting to drive study execution and operational excellence toward product development goals
  • Lead the development of CQP related sections in regulatory documents (e.g., clinical protocols, INDs, regulatory meeting briefing books, summary documents for BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions
  • Lead/oversee the Clin Pharm data analysis, interpretation, and reporting to inform clinical implications and development decisions
  • Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders
  • Mentor junior team members to contribute to the development of a high-performing Clinical Pharmacology team
  • Leverage literature data and collaborate with external consultants, CRO partners and academic sites to problem solve and develop solutions to clinical pharmacology issues and grow organizational knowledge on mRNA platform

Requirements:

  • PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology
  • In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences
  • Hands-on quantitative skills, modeling expertise and familiarity with clinical operations and translational sciences
  • Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products
  • Drug development experience in oncology and rare diseases preferred
  • expertise in immune therapeutics and/or infectious diseases is a plus
  • Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred
  • Demonstrated ability to work independently, lead functional initiatives, adapt quickly and collaborate effectively in a highly dynamic environment and influence cross-functional teams
  • Proficient in using pharmacokinetic, modeling and data visualization software (e.g. Phoenix WinNonlin, R, Monolix, NONMEM, etc)
  • Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences
  • Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis
  • Ability to develop and deliver clear and concise presentations for both internal and external meetings
  • Candidate will be curious in exploring new paths for model informed drug development
  • Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes
  • Strong publication record
  • Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams
  • Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Nice to have:

  • Drug development experience in oncology and rare diseases preferred
  • expertise in immune therapeutics and/or infectious diseases is a plus
  • Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred
What we offer:
  • Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
  • Family planning benefits, including fertility, adoption, and surrogacy support
  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investment opportunities to help you plan for the future
  • Location-specific perks and extras
  • Annual discretionary bonus, other incentive compensation, or equity award

Additional Information:

Job Posted:
May 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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