Director, Clinical Pharmacology

Role Summary

The Director, Clinical Pharmacology leads and shapes clinical pharmacology strategy within the Clinical Pharmacology group (CQP), guiding Model-Informed Drug Development (MIDD) across a multidisciplinary program team and driving execution to advance mRNA platform therapies.

Responsibilities

• Develop a fit-for-purpose Clinical Pharmacology development plan including dose selection and optimization, evaluation plans for special populations, PK/PD and immunogenicity assessment, and pediatric development.
• Collaborate with program teams to develop dose selection strategies and support decision making for first-in-human studies and IND submissions.
• Represent CQP in a matrixed team to drive study execution and operational excellence toward product development goals.
• Lead the development of CQP-related sections in regulatory documents and represent clinical pharmacology in regulatory interactions.
• Lead/oversee clinical pharmacology 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 a high-performing Clinical Pharmacology team.
• Leverage literature data and collaborate with external consultants, CROs, and academic sites to solve clinical pharmacology issues and grow knowledge on the mRNA platform.

Qualifications

• Basic: PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with 8‚Äì10+ 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.
• Solid understanding of regulatory biopharmaceutics and clinical pharmacology requirements to support development and marketing of new drugs.
• Drug development experience in oncology and rare diseases is preferred; expertise in immune therapeutics and/or infectious diseases is a plus.

Skills

• Platform expertise in mRNA therapeutics or biologics/new modalities (preferred).
• Ability to work independently, lead initiatives, adapt quickly, and influence cross-functional teams.
• Proficiency with pharmacokinetic, modeling, and data visualization software (e.g., Phoenix WinNonlin, R, Monolix, NONMEM).
• Excellent written and verbal communication; ability to distill complex data for diverse audiences.
• Track record of regulatory filings (NDA/BLA) and experience with global regulatory requirements for quantitative analysis.
• Strong presentation skills for internal and external meetings.
• Curiosity to explore new paths for model-informed drug development; collaborative across multifunctional teams; determined to achieve outcomes.
• Strong publication record and demonstrated teamwork, problem-solving, and influence across project teams.
• Excellent interpersonal communication in a highly matrixed environment.

Education

• PhD and/or PharmD in a relevant field as listed under Qualifications.

Additional Requirements

• No specific travel or physical demands stated as essential in the provided description.