Senior Director – Non-Clinical Safety Project Specialist

GSK

Senior Director/Director overseeing non-clinical safety project efforts within drug development at GSK. Providing strategic input and expert consultancy throughout project lifecycle and regulatory submissions.

Posted 7/13/2026full-timeWaltham • Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $224,400 - $374,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in non-clinical safety and regulatory submissions, integrating scientific data into strategic narratives while leading cross-functional collaboration. Proven ability to mentor and support project teams in delivering high-quality safety strategies within pharmaceutical or biotech environments.

Highest-signal resume keywords

Non-Clinical Safety ExpertiseRegulatory Submissions ExperienceCross-Functional CollaborationData Interpretation and IntegrationProject Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Non-Clinical SafetyRegulatory StrategyPharmaceutical DevelopmentBiotech Drug DevelopmentSafety ScreeningCandidate SelectionDue DiligenceScientific Data IntegrationEvidence-Based NarrativesProject Planning

Soft Skills

CommunicationNegotiationDecision SupportCoachingMentoring

Certifications & Qualifications

PhDDVMMD

Industry Keywords

INDCTANDABLAPharmacologyDMPKClinical Development

About the role

Key responsibilities & impact

Represent non-clinical safety as a Project Team Member, providing strategic input to integrated project plans
Lead or contribute to the design, coordination and delivery of optimized non-clinical safety and translational project plans
Integrate scientific data and knowledge into clear, evidence-based narratives for internal governance
Provide expert consultancy on target liabilities, candidate selection, safety screening, due diligence opportunities
Influence cross-functional stakeholders 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

Requirements

What you’ll need

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

Benefits

Comp & perks

health care and other insurance benefits (for employee and family)
retirement benefits
paid holidays
vacation
paid caregiver/parental and medical leave