Preclinical Development Consultant (w/m/d)

Permanent Contract, Full time · Baden-Württemberg (Southwest)

Ihre Aufgaben

• Strategy: Advising project teams on non-clinical strategy across various product types (including small molecules, biologics, ATMPs, and combination products).
• Planning: Designing non-clinical development plans aligned with ICH M3, ICH S6, ICH S9, and related guidelines.
• Representation: Representing non-clinical expertise during global regulatory interactions, such as scientific advice meetings.
• Management: Overseeing and coordinating non-clinical studies throughout their lifecycle.
• Compliance: Conducting GLP audits of contract research organizations (CROs).
• Safety: Performing toxicological assessments of APIs, excipients, and impurities.
• Documentation: Creating non-clinical documentation for clinical trial applications and marketing authorization submissions (e.g. CTD modules 2.4, 2.6, 4).
• Review: Reviewing and updating non-clinical content in product information (e.g. SmPC, PIL).
• Assessment: Conducting gap analyses of existing non-clinical data and reports.
• Evaluation: Evaluating non-clinical aspects of in-licensing opportunities through due diligence.

Ihr Profil

• Education: PhD in life sciences, or degree in medicine, veterinary medicine, or a related field.
• Expertise: In-depth knowledge of preclinical pharmacodynamics, pharmacokinetics, and toxicology.
• Experience: Hands-on experience in non-clinical pharmaceutical development (preferably including ATMPs or biological products).
• Background: Relevant professional experience in pharma companies, biotechs, non-clinical CROs, or regulatory bodies.
• Compliance: Familiarity with GLP standards and regulatory requirements for non-clinical development.
• Tools: Experience with in silico modeling tools such as QSAR or PBPK is an advantage.
• Understanding: Strong ability to interpret and communicate complex non-clinical development scenarios.
• Communication: Excellent verbal and written communication skills in English.
• Autonomy: Capable of working independently and managing multiple projects or tasks simultaneously.

Information über mein Kunde: My client is an internationally active service provider in the field of pharmaceutical development, based in Germany. The company offers comprehensive support to pharmaceutical and biotechnology firms in obtaining drug approvals—from early development stages through to successful market launch. Key areas of focus include regulatory affairs, pharmacovigilance, and quality management. My client stands out through many years of experience, strong scientific expertise, and a collaborative approach with partners—always with the goal of bringing safe and effective medicines to market efficiently.