AI-driven drug discovery biotech with teams across Asia, UAE, Europe, and North America. They are on the lookout for a Clinical Development Head to be based in Greater Boston area (hybrid).
Responsibilities:
Support and leads clinical pharmacology programs through early and late development.
Collaborate with internal teams as a strategic advisor on regulatory, clinical development, clinical pharmacology, pharmacometrics and other development issues.
Work closely with clinical development, clinical operations and regulatory teams
Provide strategic clinical pharmacology guidance on drug development, leveraging the use of quantitative methods such as modeling and simulations
Requirements:
PhD or PharmD or MD degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline.
3 – 5 years’ experience in the pharmaceutical industry
Practical experience on small molecule in recent years
Knowledge of regulatory process and expectations
Able to design clinical pharmacology and apply pharmacometric tools
Expert experience in providing input on clinical pharmacology plans and preparation of regulatory submissions
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