Senior Director / Director, Non-Clinical Safety Project Specialist

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

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $224,400 to $374,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call.

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