Director, Clinical Pharmacology, Clinical and Quantitative Pharmacology (CQP)

The Role
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.

The role is positioned in the Clinical Pharmacology group, Clinical and Quantitative Pharmacology (CQP) function within Moderna’s growing Therapeutics & Oncology development organization in R&D. 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 the 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.

At Moderna, we are pioneering the development of mRNA medicines to transform patients' lives. As part of our innovative team, you will play a key role in shaping the future of medicine while growing your career in a supportive, collaborative environment.

Here’s What You’ll Do

• Responsible to 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

Here’s What You’ll Bring to the Table

• 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.

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time of