ViiV Healthcare (GSK) Clinical Development Director
GSK
10 days ago
Remote friendly (Durham, NC)
United States
Clinical Research and Development
Clinical Development Director — Role Purpose
Provide scientific leadership, direction, and contribute to the strategy for ViiV Healthcare clinical development programs. Provide scientific leadership of the asset study team to design and develop high quality, timely studies end-to-end, and support study-level governance and regulatory reporting through cross-functional collaboration.
Responsibilities:
- Drive strategy for early- and/or late-stage development programs.
- Develop, finalize, and amend study protocols with internal/external stakeholder input; ensure alignment with clinical development objectives/integrated evidence plan.
- Liaise with Operations, Clinical Pharmacology, Medical, Regulatory, and Commercial Leads to ensure key aspects of the Asset Target Product Profile are evaluated.
- Co-lead Clinical Matrix Teams with the accountable physician (may).
- Provide scientific oversight to ensure data collection/analysis plans align with protocols.
- Partner with study teams to meet regulatory reporting requirements.
- Enable review of safety data; may lead identification of safety committee members and interim safety review charter preparation; monitor safety and benefit/risk.
- Oversee evidence generation and scientific outputs (investigator meeting, clinical study report, congress/journal publications, regulatory documents).
- Partner with clinical operations for optimal study delivery.
- Contribute to quality assurance and inspection readiness.
- Coach and mentor team members.
Basic Qualifications (required):
- BS/Masters/PhD/PharmD with 5+ years drug development experience (pharma or CRO) leading scientific aspects of clinical programs and regulatory submissions.
- HIV/infectious disease drug development experience.
- Experience with study protocols, informed consent forms, and clinical study reports.
- Experience reviewing/interpreting clinical and scientific data.
- End-to-end clinical development strategy experience (design, interpretation, risk assessment, milestones).
- 5+ years leading cross-functional teams.
- Experience managing multiple programs concurrently.
Preferred Qualifications (plus):
- HIV drug development across multiple phases; regulatory interactions/submissions.
- Strong influence/leadership without formal authority.
- Communicate complex science/clinical information to senior governance forums.
Application instruction:
- For accommodation/assistance applying: usrecruitment.adjustments@gsk.com.
Benefits:
- Refer to GSK US Benefits Summary (ViiV employees receive GSK benefits options/plans).
Provide scientific leadership, direction, and contribute to the strategy for ViiV Healthcare clinical development programs. Provide scientific leadership of the asset study team to design and develop high quality, timely studies end-to-end, and support study-level governance and regulatory reporting through cross-functional collaboration.
Responsibilities:
- Drive strategy for early- and/or late-stage development programs.
- Develop, finalize, and amend study protocols with internal/external stakeholder input; ensure alignment with clinical development objectives/integrated evidence plan.
- Liaise with Operations, Clinical Pharmacology, Medical, Regulatory, and Commercial Leads to ensure key aspects of the Asset Target Product Profile are evaluated.
- Co-lead Clinical Matrix Teams with the accountable physician (may).
- Provide scientific oversight to ensure data collection/analysis plans align with protocols.
- Partner with study teams to meet regulatory reporting requirements.
- Enable review of safety data; may lead identification of safety committee members and interim safety review charter preparation; monitor safety and benefit/risk.
- Oversee evidence generation and scientific outputs (investigator meeting, clinical study report, congress/journal publications, regulatory documents).
- Partner with clinical operations for optimal study delivery.
- Contribute to quality assurance and inspection readiness.
- Coach and mentor team members.
Basic Qualifications (required):
- BS/Masters/PhD/PharmD with 5+ years drug development experience (pharma or CRO) leading scientific aspects of clinical programs and regulatory submissions.
- HIV/infectious disease drug development experience.
- Experience with study protocols, informed consent forms, and clinical study reports.
- Experience reviewing/interpreting clinical and scientific data.
- End-to-end clinical development strategy experience (design, interpretation, risk assessment, milestones).
- 5+ years leading cross-functional teams.
- Experience managing multiple programs concurrently.
Preferred Qualifications (plus):
- HIV drug development across multiple phases; regulatory interactions/submissions.
- Strong influence/leadership without formal authority.
- Communicate complex science/clinical information to senior governance forums.
Application instruction:
- For accommodation/assistance applying: usrecruitment.adjustments@gsk.com.
Benefits:
- Refer to GSK US Benefits Summary (ViiV employees receive GSK benefits options/plans).