Clinical Development Director
Location: Durham Blackwell Street, UK – London – New Oxford Street.
Responsibilities
- Helps drive the strategy of ViiV Healthcare early‑ and/or late‑stage development programs
- Accountable for the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring the protocol fulfills the strategic objective of clinical development/ integrated evidence plan
- Liaises with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to ensure the study/program evaluates key aspects of the Asset Target Product Profile critical to product differentiation/reimbursement where possible
- May co‑lead Clinical Matrix Teams with the accountable physician
- Provides scientific oversight of clinical studies, ensuring data collection and study analysis plans align with protocols and allow intended scientific interpretation of study data and results
- Partners with the study team to ensure all regulatory reporting requirements are met
- Collaborates with physicians and other study team members and stakeholders to enable appropriate review of safety data; may assist or take a leading role in identification of safety review committee members and preparation of an interim safety review charter document; works closely with study physician(s) to help monitor safety and benefit/risk for studies
- Works with the study team to create evidence generation and scientific outputs, including content of investigator meetings, clinical study reports, preparation of study results for scientific meetings, congresses and external journal publications, regulatory documents and other relevant study documents
- Partners with clinical operations colleagues to ensure optimal delivery of study while maintaining close collaborations with other functions supporting the study
- Contributes to quality assurance and inspection readiness activities
- Coaches and mentors team members
- Partners across ViiV Healthcare and the broader GSK enterprise to provide clinical science, R&D, and ViiV Healthcare perspectives on key business priorities
Basic Qualification
- B.S. or Masters or Ph.D. or Pharm.D., with 5+ years of recent drug development experience in a pharmaceutical industry or CRO environment leading the scientific aspects of clinical program(s) and regulatory submission(s)
- Prior drug development experience in HIV / infectious diseases
- Experience in working with or writing study protocols, informed consent forms and clinical study reports
- Experience with reviewing and interpreting clinical and scientific data
- Experience contributing to end‑to‑end clinical development strategy, including study design, data interpretation, risk assessment, and milestone planning
- Experience translating complex study‑level issues into broader program‑level recommendations and decisions
- 5+ years leading cross‑functional teams, including internal and external partners (e.g., 3rd parties, academic partners, and subcontracted organizations)
- Experience with managing multiple programs concurrently
Preferred Qualification
- HIV drug development experience, including experience across multiple phases of development and contribution to regulatory interactions/submissions
- Strong track record of influencing cross‑functional strategy and driving alignment across internal and external stakeholders without formal authority
- Ability to communicate complex scientific and clinical information effectively to senior governance forums and cross‑functional leadership teams
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employees.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com.
ViiV 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.
#J-18808-Ljbffr…