Head of Unit BTC, ATMP, and IVD Vigilance | Biologe (m/w/d)
Paul-Ehrlich-Institut
Job Summary
This leadership role at the Paul-Ehrlich-Institut involves managing the 'BTC, ATMP, and IVD Vigilance' unit, which oversees the safety of blood products, tissue preparations, advanced therapy medicinal products (ATMPs), and high-risk in-vitro diagnostics (IVD Class D). As the Head of Unit, you will lead an interdisciplinary team of scientists and regulatory experts, ensuring the quality of operational activities such as planning pharmaceutical inspections and evaluating risk-benefit profiles. You will represent the institute in national and international committees, advise the institute's leadership, and develop strategies to optimize regulatory processes. This position is ideal for a senior professional with a strong background in life sciences and drug safety who wants to influence public health standards at a federal level. The role offers the stability of public service employment in the Rhine-Main region, including a permanent contract and the possibility of civil servant status.
Required Skills
Education
University degree (Master's or equivalent) in life sciences, natural sciences, or health sciences (e.g., Human Medicine, Pharmacy, Biology, Public Health) plus a completed Doctorate (PhD) in a relevant field.
Experience
- Professional experience in drug safety or pharmaceutical licensing
- Initial experience in personnel leadership, team building, and organizational management
- Extensive knowledge in immunology, pharmacology, and biomedicine
- Experience with clinical drug trials regarding safety aspects is preferred
- Experience representing organizations in national or international committees
Languages
Additional
- Must submit a Declaration of Interests to the EMA and a declaration according to § 77a AMG upon hiring. Willingness for occasional national and international travel is required.
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