Non-Clinical Drug Safety Senior Project Manager
Non-Clinical Drug Safety Senior Project Manager
Ipsen Pharma
Les Ulis, France
Job Description:
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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