Position Summary
This key Non-Clinical Safety Leadership role will act as a Project Team Member, consultant, mentor and reviewer across discovery and development projects. Accountable for the quality of scientific thinking and outputs that characterise non-clinical safety, drug disposition and on-/off-target engagement for potential therapies, integrating data and knowledge into clear project narratives, optimized development plans, regulatory documents and decision-making. Through direct project delivery, cross-functional influence and support of the wider PTM community, enable the safe and efficient progression of medicines through clinical development, approval and, where required, post-market support.
Key Responsibilities
- Represent non-clinical safety as a Project Team Member, providing strategic input to integrated project plans across discovery, development and, where required, post-market support.
- Lead or contribute to the design, coordination and delivery of optimized non-clinical safety and translational project plans that support key decision points.
- Integrate scientific data and knowledge into clear, evidence-based narratives for internal governance, project strategy, regulatory documents, submissions and responses to regulatory questions.
- Provide expert consultancy on target liabilities, candidate selection, safety screening, on-/off-target engagement, due diligence opportunities and marketed product issues as required.
- Influence cross-functional stakeholders, governance bodies and regulators through high-quality scientific judgement, communication, negotiation and decision support.
- Support capability and quality across the PTM community through coaching, mentoring, training, peer review and approval of key internal and regulatory documents.
- Contribute to regulatory strategy and lead or support global regulatory submissions (e.g. CTA, IND, MAA, NDA), ensuring aligned non-clinical safety positions and high-quality documentation.
- Lead or provide significant input to major scientific or technical initiatives, including organisational changes affecting non-clinical safety and DMPK project delivery.
- Ensure clear line of sight and leadership on project safety issues and progression challenges, leveraging relevant SMEs as required.
- Promote flexible, courageous scientific thinking by providing multiple options and risk–benefit perspectives to project teams, EDLs/MDLs and governance bodies.
Basic Qualifications:
- Advanced degree (PhD, DVM, MD or equivalent) in a relevant scientific discipline
- Significant experience in non-clinical safety within pharmaceutical or biotech drug development
- Experience supporting regulatory submissions (e.g. IND, CTA, NDA, BLA)
- Demonstrated ability to lead or contribute to non-clinical safety strategies across discovery and/or development
- Strong cross-functional collaboration skills with disciplines such as Pharmacology, DMPK, and Clinical Development
- Proven ability to interpret and integrate complex data into regulatory and strategic narratives
Preferred Qualifications:
- Experience with complex NCE and biologic modalities
- Recognised expertise in a specialist area of toxicology (e.g. genetic, reproductive, inhalation)
- Professional certification (e.g. DABT, ERT)
- Established external scientific reputation (publications, advisory roles, regulatory interactions)
- Experience mentoring and developing other scientists or PTMs
- Track record of leading major scientific or organisational initiatives
- Experience influencing senior governance bodies and regulatory agencies
