Purpose:

Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies. Consistently demonstrates excellent record of accomplishment of Clinical Pharmacology and business objectives. Leads Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.

Responsibilities

• Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).
• Executes strategy, lead teams and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).
• Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant section of investigator brochures, white papers, and other similar documents.
• Leads clinical pharmacology and biopharmaceutics meetings, serve as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team and present at various departmental and cross functional teams such as study teams, CLINICAL PHARMACOLOGY leadership team, Journal club.
• Drives small teams with members from CLINICAL PHARMACOLOGY functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
• Authors scientific publications and present at national and international conferences and interact with KOLs/external stakeholders.
• Conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
• Represents Clinical Pharmacology at regulatory meetings.