Director, Nonclinical Due Diligence & External Innovation
CSL · Waltham, MA · 3 days ago
HybridHealthcareFull-time
Responsibilities
- Leads operational execution of nonclinical due diligence for assigned opportunities.
- Acts as hands-on scientific integrator, translating expert input into clear risk narratives.
- Trusted subject-matter lead for nonclinical DD on individual deals.
- Lead end-to-end nonclinical due diligence for individual assets or transactions, from request through final governance readout.
- Integrate input from Toxicology, PK/QSP, Nonclinical Pharmacology, and external experts into a single, coherent scientific assessment.
- Identify FIH-enabling gaps, translational risks, and regulatory limitations, with clear mitigation proposals.
- Prepare high-quality DD reports, executive summaries, and risk tables for governance review.
- Act as NCD scientific interface to Business Development and Therapeutic Area teams at the project level.
- Contribute to maintenance and continuous improvement of nonclinical DD frameworks and templates.
- Mentor junior contributors and matrix team members as appropriate.
- Escalates complex or high-impact issues to Head of NCD
- Chair of “NCD Review Committee”
Qualifications
- Advanced degree (Ph.D., D.V.M., or equivalent) in toxicology, pharmacology, or a related field.
- Toxicology training, board certification preferred.
- Experience in nonclinical development (10+ years) with proven experience in due diligence or external innovation, ideally across various geographies.
- Strong understanding of FIH-enabling nonclinical requirements, particularly for biologics and complex modalities.
- Ability to communicate complex scientific risk clearly to non-expert stakeholders.
- Experience across multiple therapeutic areas and modalities is highly desirable.