Senior Preclinical & Translational lead - Oncology

Job Summary

We are seeking a highly experienced Preclinical & Translational Lead to bridge preclinical development, translational research, and Phase 1 clinical trials.

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.