Non-Clinical Drug Safety Senior Project Manager H/F

Missions:

• Optimize nonclinical development plans for products.
• Collaborate with project/asset teams to deliver optimized development plans.
• Handle non-clinical drug safety aspects in various documents (lB, CIA, IMPD, IND, Briefing documents, Expert reports).
• Contribute to non-clinical modules for submissions.
• Represent the nonclinical function during EU & US agency consultations.
• Identify external experts for issue resolution.
• Master a discipline within preclinical safety.
• Serve as a safety expert for “In or Out-Licensing” activities.

EHS Responsibilities:

• Comply with applicable EHS regulations and procedures.
• Report risks, malfunctions, or improvements related to EHS performance.
• Participate in mandatory EHS training.

Education / Certifications:

• Doctorate level in Toxicology (DVM, Pharm D, MD, or PhD).
• Board certification (ABT or ACVP) is a plus.

Experience:

• Minimum of 10 years in the pharmaceutical industry.

Key Technical Competencies Required:

• Strong scientific knowledge of toxicology (genotoxicity, reproductive toxicology, general toxicology, investigational toxicology).
• Ability to think transversally and understand factors influencing research and development.

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