Clinical Development Director, Oncology
GSK
4 months ago
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Position Summary
- Lead clinical development activities advancing oncology programs from early studies through regulatory interactions.
Responsibilities
- Provide clinical leadership for study strategy and design (Phase I–IV) aligned with CDP, asset profile, and regulatory expectations.
- Lead protocol development from concept to final study report; author/review CSP, Investigator’s Brochure (IB), and clinical sections of regulatory submissions.
- Ensure study objectives/endpoints and safety monitoring meet regulatory/ethical/medical governance standards; establish/monitor Go/No-Go criteria.
- Integrate internal/external scientific evidence to shape strategy and interpret findings.
- Lead clinical matrix teams; collaborate with Clinical Operations, Biostatistics, Clinical Pharmacology, Safety/Pharmacovigilance, Regulatory Affairs to deliver on time/quality/budget.
- Provide clinical input to regulatory interactions/submissions; prepare briefing materials and support meetings.
- Oversee clinical safety reporting (DSURs/expedited), coordinate with Ethics Committees/IRBs and IDMCs.
- Drive clinical interpretation for CSRs and external scientific outputs; represent programs externally as required.
Basic Qualifications
- Master’s degree in life science/medicine (or equivalent) with relevant clinical research experience.
- Oncology or immuno-oncology clinical development experience (early and late phases).
- Proven matrix leadership; influence cross-functional stakeholders.
- Knowledge of UK/EU regulatory frameworks (MHRA, HRA, EMA) and international submissions.
- Strong clinical judgment, data interpretation, and communication.
- Minimum 2 years clinical scientist experience (oncology preferred).
Preferred Qualifications
- Immuno-oncology/advanced oncology modalities and biomarkers; clinical pharmacology/translational medicine.
- Process change/improvement; advanced clinical degree (MD/PhD/PharmD/RN) or equivalent.
- Regulatory submissions and Scientific Advice/EoP2; safety governance (IDMC/ISRC). Publication/conference experience.
Benefits (explicitly stated)
- Annual bonus; share-based long-term incentive eligibility; health care/insurance, retirement, paid holidays/vacation, caregiver/parental and medical leave.
Application Instructions
- Apply to join the team; if ready to lead clinical development, submit your application.
- Lead clinical development activities advancing oncology programs from early studies through regulatory interactions.
Responsibilities
- Provide clinical leadership for study strategy and design (Phase I–IV) aligned with CDP, asset profile, and regulatory expectations.
- Lead protocol development from concept to final study report; author/review CSP, Investigator’s Brochure (IB), and clinical sections of regulatory submissions.
- Ensure study objectives/endpoints and safety monitoring meet regulatory/ethical/medical governance standards; establish/monitor Go/No-Go criteria.
- Integrate internal/external scientific evidence to shape strategy and interpret findings.
- Lead clinical matrix teams; collaborate with Clinical Operations, Biostatistics, Clinical Pharmacology, Safety/Pharmacovigilance, Regulatory Affairs to deliver on time/quality/budget.
- Provide clinical input to regulatory interactions/submissions; prepare briefing materials and support meetings.
- Oversee clinical safety reporting (DSURs/expedited), coordinate with Ethics Committees/IRBs and IDMCs.
- Drive clinical interpretation for CSRs and external scientific outputs; represent programs externally as required.
Basic Qualifications
- Master’s degree in life science/medicine (or equivalent) with relevant clinical research experience.
- Oncology or immuno-oncology clinical development experience (early and late phases).
- Proven matrix leadership; influence cross-functional stakeholders.
- Knowledge of UK/EU regulatory frameworks (MHRA, HRA, EMA) and international submissions.
- Strong clinical judgment, data interpretation, and communication.
- Minimum 2 years clinical scientist experience (oncology preferred).
Preferred Qualifications
- Immuno-oncology/advanced oncology modalities and biomarkers; clinical pharmacology/translational medicine.
- Process change/improvement; advanced clinical degree (MD/PhD/PharmD/RN) or equivalent.
- Regulatory submissions and Scientific Advice/EoP2; safety governance (IDMC/ISRC). Publication/conference experience.
Benefits (explicitly stated)
- Annual bonus; share-based long-term incentive eligibility; health care/insurance, retirement, paid holidays/vacation, caregiver/parental and medical leave.
Application Instructions
- Apply to join the team; if ready to lead clinical development, submit your application.