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ID: 99627 We are seeking a highly experienced Preclinical & Translational Lead to bridge preclinical development, translational research, and Phase 1 clinical trials. This is a contract role for 6 months and requires 3 days per week with 2 of them days being based on site in Lyon. As our Senior Preclinical & Translational Lead – Oncology, you will play a pivotal role in advancing our oncology portfolio from preclinical stages through Phase 1 clinical trials. You will: • Lead translational research to support first-in-human (FIH) studies., • Oversee preclinical development, including Investigator’s Brochure (IB) writing, nonclinical safety assessments, and support regulatory submissions., • Drive biomarker development in collaboration with the internal research team and external stakeholders., • Work closely with clinical sites to ensure seamless translational execution in Phase 1 trials., • Provide scientific leadership to cross-functional teams (discovery, clinical, regulatory, CMC). This role is ideal for a PhD/PharmD-level scientist with 5+ years of industry experience (biotech) in oncology drug development, a strong translational mindset, and a track record of successful IND/CTA filings and Phase 1 execution. Key Responsibilities Preclinical & Translational Strategy • Lead the design and execution of preclinical studies (efficacy, PK/PD, toxicology) to support IND/CTA filings., • Author and review Investigator’s Brochures (IBs), nonclinical summaries, and regulatory documents (e.g., IMPDs, CTDs)., • Develop translational research plans to enable patient stratification and biomarker-driven trials., • Collaborate with discovery teams to ensure mechanistic understanding of drug candidates., • Collaborate with CMC experts and CDMO on formulation, manufacturing, and stability studies. Biomarker Development & Clinical Translation • Design and implement biomarker strategies (PD, predictive, resistance) for Phase 1 trials., • Ensure smooth transition from preclinical to clinical stages by aligning with clinical operations, biostatistics, and regulatory teams., • Serve as the translational science lead for FIH/Phase 1 oncology trials, working closely with clinical sites. Qualifications & Experience Required: • PhD in Oncology or PharmD with relevant experience with immuno-oncology, therapeutic vaccine, cell therapy., • 5+ years of industry experience in oncology drug development, with a focus on preclinical and translational research., • Familiarity with regulatory submissions process : Proven track record in IND/CTA filings, IB writing, and Phase 1 trial support., • Deep expertise in biomarker development., • Strong understanding of oncology pathways (e.g., immuno-oncology, therapeutic vaccine, cell therapy)., • Experience working with clinical sites, and regulatory agencies (FDA, EMA)., • Excellent scientific writing and communication skills (English & French preferred)., • Ability to work in a fast-paced, matrixed environment with strong project management skills.