Clinical Pharmacology/DMPK : Sr Consultant PK/PD

Remote: USA based

Overview: We are seeking a seasoned expert to oversee Clinical Pharmacology/DMPK activities within the Regulatory Affairs and Drug Delivery Solutions (RADDS) department. This senior role involves shaping complex product development strategies across drugs, biologics, and biotechnology products, ensuring high‑quality deliverables that meet timelines, budgets, and regulatory standards. You will provide strategic input into development plans, study designs, regulatory submissions, and serve as a trusted advisor in your area of expertise.

Key Responsibilities: Act as the senior Clinical Pharmacology/DMPK subject matter expert (SME), supporting regulatory business development and bid defense strategies. Provide consulting support across PK, PD, DMPK, and biopharmaceutics for small molecules, biologics (including biosimilars), gene therapies, and drug‑device products. Conduct gap analyses, due diligence reviews, and regulatory assessments aligned with FDA/EMA guidance and industry best practices. Contribute to target product profiles, integrated clinical development plans, pediatric plans, and free‑standing clinical pharmacology strategies. Design and support Phase 1 clinical pharmacology, drug interaction, and PD studies, as well as PK/PD components in later‑phase trials. Guide dose selection for first‑in‑human and pivotal studies, ensuring robust PK/PD evaluation. Provide technical input and review for clinical trial synopses, protocols, and regulatory submissions (IND, CTD, PSP/PIP).Represent sponsors in regulatory meetings (pre‑IND, EoP1, EoP2, pre‑BLA/NDA, Scientific Advice).Lead cross‑functional initiatives and serve as a global contact for key clients.

Required Knowledge, Skills & Abilities: Progressive leadership experience in pharma, biotech, or CRO environments. Extensive expertise in clinical pharmacology and DMPK strategies, including study design and execution across multiple modalities and routes of administration. Proven track record in dose selection, PK/PD sampling strategies, and data interpretation; modeling/simulation experience preferred. Strong background in regulatory and technical writing, including clinical pharmacology sections of submissions. Direct experience with regulatory agency interactions. Familiarity with drug‑device products, gene therapies, vaccines, and bioanalytical assay development is a plus. Advanced communication, negotiation, and leadership skills with the ability to influence at senior levels. Proficiency in MS Office and related software tools.

Education: Advanced degree in a life science discipline (PhD, PharmD, MD, or equivalent) plus extensive strategic clinical pharmacology/DMPK regulatory experience.