Key skills
Statistical Analysis
About this role
Role Overview
- 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