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This job expired on 27/09/2026. It no longer accepts applications.
Senior Director, Non-Clinical Safety Project Specialist
GSK · Stevenage
Job description
About the role
This senior leadership position at GSK is responsible for shaping non‑clinical safety strategy across discovery and development programmes. The role combines project delivery, scientific mentorship and regulatory expertise to ensure safe progression of drug candidates.
Key responsibilities
- Represent non‑clinical safety on project teams, providing strategic input from discovery through post‑market support.
- Design, coordinate and deliver optimized safety and translational plans that inform key decision points.
- Integrate scientific data into clear, evidence‑based narratives for internal governance, regulatory submissions and stakeholder communications.
- Advise on target liabilities, candidate selection, safety screening and on‑/off‑target engagement.
- Influence cross‑functional teams, governance bodies and regulators through high‑quality scientific judgement and negotiation.
- Coach, mentor and review internal and regulatory documents to uphold quality across the PTM community.
- Contribute to global regulatory strategies and lead or support submissions such as CTA, IND, MAA and NDA.
- Drive major scientific initiatives and organisational changes affecting non‑clinical safety and DMPK delivery.
Required profile
- Advanced degree (PhD, DVM, MD or equivalent) in a relevant scientific discipline.
- Extensive experience in non‑clinical safety within pharmaceutical or biotech drug development.
- Proven ability to lead multi‑disciplinary projects and influence senior stakeholders.
Required skills
- Non‑clinical safety expertise
- Toxicology and pharmacokinetics (DMPK)
- Regulatory submission preparation (CTA, IND, MAA, NDA)
- Scientific data integration and narrative development
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GSK
Stevenage