Director leading Clinical Pharmacology studies at Novartis, managing studies while ensuring scientific quality and safety standards. Collaborating with cross‑functional teams to influence the development pipeline.
Responsibilities
Lead and manage multiple FiH and Clinical Pharmacology studies simultaneously with medical, scientific, and operational excellence
Provide expert Clinical Pharmacology input into Study Concept Sheets, protocols, Informed Consent Forms, Statistical Analysis Plans, and TLF shells
Oversee medical and safety aspects of studies, including Site Initiation Visits, ongoing safety reviews, medical coding, and safety reporting
Drive development of Clinical Study Reports and contribute to dissemination of study results (e.g., abstracts, posters, manuscripts, plain‑language and technical summaries)
Provide strategic Clinical Pharmacology guidance to ensure optimal study design aligned with program objectives
Partner with project‑level TMEs to align on compound background and program strategy
Lead or contribute to strategic initiatives, process optimization, and capability‑building efforts
Requirements
Medical degree (MD) combined with a PhD/post‑doctoral training, board certification, or relevant Clinical Pharmacology research experience
Significant experience in FiH and Clinical Pharmacology studies—either in biotech/pharma, as a PI/sub‑investigator at a CRO, or at an academic medical center
Proven track record of contributions to drug development, regulatory submissions, or high‑quality scientific publications
Experience within a TM therapeutic area is an asset
Full professional proficiency in English (spoken and written)
Benefits
Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development
Job title
Director, Translational Medicine Expert, Clinical Pharmacology
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