Responsibilities:
- Accountable for Phase 1β4 studies design and clinical pharmacology strategy; representative for project(s).
- Execute strategy; lead teams; perform data analyses and interpretation with context (MoA/disease specifics, internal/external data, analysis plans, model interpretation).
- Author regulatory documents (protocols, study reports, population PK, exposure-response analyses, CTDs, label sections, relevant investigator brochure sections, white papers).
- Lead clinical pharmacology and biopharmaceutics meetings; serve as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team; present to cross-functional teams.
- Drive small teams from Clinical Pharmacology functional groups to provide unified clinical pharmacology positions to clinical, CMC, and regulatory teams.
- Author scientific publications; present at national/international conferences; interact with KOLs/external stakeholders.
- Conduct due diligence assessments; summarize results; represent Clinical Pharmacology on business development teams.
- Represent Clinical Pharmacology at regulatory meetings.
Qualifications:
- PhD with 4+ years (or PharmD with 6+ years) in a relevant field; plus Masterβs (12+ years) or Bachelorβs (14+ years). Relevant field includes PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills; ability to interact with internal/external functional representatives and KOLs; lead teams.
- Strategic thinking and enterprise view; proven scientific track record and technical skills.
- Leadership competencies: deliver business results; persistence; act respectfully/courageously; generate original ideas; influence cross-functional alignment; accountability in delegation and being delegated to.