The Senior Director manages strategic, scientific and operational aspects of multiple programs from the clinical pharmacology perspective.

Serves as the Global Clinical Pharmacology Lead for assets across phases 1-4 of development. Works closely with functional experts across the R&D organization, such QS, Research, Biostatistics, Regulatory Affairs, DMPK, Pharm Sci, and Clinical Science providing leadership and guidance in clinical pharmacology activities.

Assists in departmental management through program reviews and collaborative decision-making.

Supervises and mentors junior staff providing professional and career development Position Accountabilities

Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple programs on Global Program Teams and associated scientific and operational sub-teams.

Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., QS and DMPK). Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans to enable Model-Informed Drug Development (MIDD).

Works closely with colleagues in QS to ensure strategic integration of advanced modeling and simulation approaches (e.g., QSP, MBMA) across the development continuum to inform internal decisions and external regulatory interactions.

Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis and reporting.

Responsible for clinical pharmacology summary documents (such as IB, CTA, CTD Module 2 documents, product labeling).

Oversee and/or independently perform PK/PD analyses including the interpretation of PK/PD data and associated statistical analyses in close partnership with external CRO partners.

Maintains a high standard for good clinical practice, compliance and ethics.

Mentors junior staff to ensure they value scientific excellence.

Represents Clinical Pharmacology in meetings with global regulatory agencies for his/her assigned programs.

Participates as a member of Business Development due diligence, when required.