Cogent Biosciences
gastrointestinal stromal tumors (GIST) • Oncology • Systemic Mastocytosis • kinase inhibitors
51 - 200
Director - Clinical Pharmacology
October 8
Cogent Biosciences
gastrointestinal stromal tumors (GIST) • Oncology • Systemic Mastocytosis • kinase inhibitors
51 - 200
Description
• Cogent Biosciences develops solutions for genetically driven diseases, seeking a Director of Clinical Pharmacology. • The Director will lead clinical pharmacology development while coordinating with cross-functional teams. • This role involves regulatory filings and ensuring optimal dosing in clinical studies.
Requirements
• Ph.D. or equivalent degree in pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or related field with minimum of 8+ years of experience in biopharmaceutical industry. • Strong data analysis skills and an in-depth knowledge of pharmacokinetic theory, modeling and simulation methods utilizing the latest computational approaches. • Hands-on experience in non-compartmental PK analysis and inclusion of data in the preparation of internal/external presentations, study reports and sections of regulatory submission documents. • Hands-on modeling experience using WinNonlin, GastroPlus, SimCYP, NONMEM, Monolix and/or other modeling software is highly desired. • Current knowledge of FDA regulatory guidance related to clinical pharmacology; recent experience having direct interaction with FDA is required. • Clinical pharmacology experience with small molecules in the area of oncology and rare diseases is desired. • Excellent written and oral communication skills and ability to convey complex PK and PK/PD analysis methodology and outcomes to internal and external stakeholders. • Ability to work effectively in a dynamic, collective team environment and drive alignment among multiple stakeholders is essential. • Direct experience in vendor management is required.
Benefits
• Competitive pay • Performance-based bonus • Stock options • Insurance coverage (health, dental, life, and disability) • Competitive time-off • 401(k) plan • Commuter/parking benefits
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