Non-Clinical Drug Safety Senior Project Manager H/F

Title:

Non-Clinical Drug Safety Senior Project Manager H/F

Company:

Ipsen Innovation (SAS)

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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Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.