Medical Director, Clinical Development, Respiratory
GSK
3 months ago
On-site
Collegeville, PA
Clinical Research and Development
Medical Director, Clinical Development, Respiratory (on-site: minimum two days/week at a GSK US (PA or MA) or UK (Stevenage or London HQ) site)
Responsibilities:
- Contribute to indication planning and cross-functional deliverables (TMP, CDP, study protocols, IES/planning).
- Support development and execution of IES, including oversight of R&D evidence generation to ensure patient safety and study delivery.
- Design and execute clinical development plans across advanced development stages.
- Oversee clinical study timelines and documents (protocols, amendments, investigator brochures, clinical study reports).
- Support regulatory interactions and documents; may lead responses to regulatory questions.
- Provide medical monitoring and safety oversight of study participants.
- Act as clinical lead for clinical studies (SLT; clinical point of contact on CMT with internal and external experts).
- Contribute to global regulatory submissions/files (IND, NDA, BLA, MAA).
- Evaluate business development activities (due diligence) and support strategic Clinical Development initiatives using innovative methods/digital tools.
- Stay current on therapeutic area research, trial methodologies, competitive/regulatory landscape.
Basic Qualifications:
- Medical Degree.
- Postgraduate clinical training (e.g., Internal Medicine, Primary Care/Family Medicine) leading to board eligibility/certification.
- Clinical research and drug development experience, including respiratory disease experience.
Preferred Qualifications:
- Specialty training and board qualification/registration in Pulmonary/Pulmonary & Critical Care/Respiratory Medicine.
- Global pharma/biotech respiratory experience.
- Led global trials; contributed to NDA/BLA/MAA submissions.
- Late-stage respiratory development; designed/initiated/executed/closed Phase 2 & Phase 3 trials.
Benefits (explicitly stated):
- Annual bonus; share-based long-term incentive eligibility; health/insurance, retirement, paid holidays/vacation, paid caregiver/parental and medical leave.
Responsibilities:
- Contribute to indication planning and cross-functional deliverables (TMP, CDP, study protocols, IES/planning).
- Support development and execution of IES, including oversight of R&D evidence generation to ensure patient safety and study delivery.
- Design and execute clinical development plans across advanced development stages.
- Oversee clinical study timelines and documents (protocols, amendments, investigator brochures, clinical study reports).
- Support regulatory interactions and documents; may lead responses to regulatory questions.
- Provide medical monitoring and safety oversight of study participants.
- Act as clinical lead for clinical studies (SLT; clinical point of contact on CMT with internal and external experts).
- Contribute to global regulatory submissions/files (IND, NDA, BLA, MAA).
- Evaluate business development activities (due diligence) and support strategic Clinical Development initiatives using innovative methods/digital tools.
- Stay current on therapeutic area research, trial methodologies, competitive/regulatory landscape.
Basic Qualifications:
- Medical Degree.
- Postgraduate clinical training (e.g., Internal Medicine, Primary Care/Family Medicine) leading to board eligibility/certification.
- Clinical research and drug development experience, including respiratory disease experience.
Preferred Qualifications:
- Specialty training and board qualification/registration in Pulmonary/Pulmonary & Critical Care/Respiratory Medicine.
- Global pharma/biotech respiratory experience.
- Led global trials; contributed to NDA/BLA/MAA submissions.
- Late-stage respiratory development; designed/initiated/executed/closed Phase 2 & Phase 3 trials.
Benefits (explicitly stated):
- Annual bonus; share-based long-term incentive eligibility; health/insurance, retirement, paid holidays/vacation, paid caregiver/parental and medical leave.