Director, Clinical Pharmacology

Develop a fit-for-purpose Clinical Pharmacology development plan, encompassing dose selection and optimization, evaluation plans for special populations, PK/PD and immunogenicity assessment, and pediatric development.,Collaborate with program teams to formulate dose selection strategies and support decision-making for first-in-human studies and IND submissions.,Represent CQP in a highly matrixed team environment, driving study execution and operational excellence to achieve product development goals.,Lead the preparation of CQP-related sections in regulatory documents (e.g., clinical protocols, INDs, briefing books, summary documents for BLAs) and represent clinical pharmacology in regulatory interactions.,Lead and oversee clinical pharmacology data analysis, interpretation, and reporting to inform clinical implications and development decisions.,Advocate for and represent clinical pharmacology and MIDD strategies with internal and external stakeholders.,Mentor junior team members to foster the development of a high-performing Clinical Pharmacology team.,Leverage literature data and collaborate with external consultants, CRO partners, and academic sites to solve clinical pharmacology issues and expand organizational knowledge on the mRNA platform.

PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field.,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 for new drug product development and marketing.,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, influencing cross-functional teams.,Proficiency in pharmacokinetic, modeling, and data visualization software (e.g., Phoenix WinNonlin, R, Monolix, NONMEM).,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, along with 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.

PhD and/or PharmD

Employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position due to the nature of the work and regulatory requirements. Moderna is unable to sponsor non-U.S. persons for an export control license for this role.