This position acts as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary program and study teams. This position is responsible for clinical pharmacology programs of assigned projects and will be the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned projects. This position will work in close collaboration with different functions including Clinical, Non-clinical, Research, Regulatory, and Biometrics. The level of this position will depend on the experience and qualification of the candidate.
- Responsible for the design and implementation of the Clinical Pharmacology plans using traditional and model informed drug development approaches and will manage the clinical study process from protocol development to final study reporting.
- Lead Clinical Pharmacology strategy and planning for clinical programs
- Ensure timely and accurate communication of study results and interpretation to appropriate internal drug development teams
- Evaluate and perform hands-on analysis of clinical PK/PD data; authorize and review PK clinical study reports
- Provide PK/PD modeling to support dosing strategies for clinical programs
- Prepare Clinical Pharmacology components of investigator brochures and regulatory submissions; represent Clinical Pharmacology line at meetings with regulatory agencies and health authorities.
- Maintain a current understanding of PK literature and methodology, as well as the scientific literature related to specific drug discovery and development projects
- Ensure appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements
Education & Experience
- PhD, MD, or PharmD with relevant expertise in pharmacokinetics, pharmacology or pharmaceutical science is required; minimum of 3+ years of direct industry experience in conducting clinical stage drug development
- Experienced in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
- Experienced in responding to regulatory questions related to all aspects of clinical pharmacology.
- Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology.
- Population PK/PD analysis and PBPK modeling experience is a plus
- Experience in working with external CROs and timely delivery of clear, accurate and well written study findings
- Strong knowledge of clinical drug development and regulatory guidance documents is essential
- Must be experienced and skilled in working with matrix teams.