Director, Clinical Development, Respiratory
GSK
4 months ago
Remote friendly (California, United States)
United States
Clinical Research and Development
Director, Clinical Development, Respiratory
Responsibilities:
- Contribute to project team indication planning; support deliverables (Target Medicine Profile, clinical development plan, study protocols, integrated evidence strategy).
- Support development/execution of the integrated evidence strategy and oversee evidence generation for patient safety and study delivery.
- Design and execute clinical development plans across advanced stages using internal/external stakeholder input.
- Oversee development of clinical study protocols/amendments, investigator brochures, and clinical study reports.
- Provide input to or lead regulatory interactions and documents (briefing documents, presentations, question responses).
- Provide medical monitoring and safety oversight for study participants.
- Serve as clinical lead for a study (Study Leadership Team) and clinical point of contact for Clinical Matrix Team; partner with internal/external experts.
- Contribute to global regulatory submissions (IND, NDA, BLA, MAA) and regulatory responses.
- Evaluate business development activities (due diligence) and help implement clinical development initiatives using innovative/digital tools.
- Stay current on therapeutic area research, clinical trial methods, competitive/regulatory landscape.
Qualifications:
- Required: Degree in Nursing or Medical related field; experience in clinical research and drug development, including respiratory disease experience.
- Preferred: Medical degree with pulmonary/respiratory specialty training and board qualification/registration; global pharma/biotech respiratory experience; lead global trials and contribute to NDA/BLA/MAA; late-stage respiratory (Phase 2/3) trial design/initiation/execution/closure.
Compensation/Benefits (as stated): US base salary ranges $178,200–$297,000 (certain locations) or $162,000–$270,000 (other US); annual bonus; share-based long-term incentive eligibility; health/insurance, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.
Responsibilities:
- Contribute to project team indication planning; support deliverables (Target Medicine Profile, clinical development plan, study protocols, integrated evidence strategy).
- Support development/execution of the integrated evidence strategy and oversee evidence generation for patient safety and study delivery.
- Design and execute clinical development plans across advanced stages using internal/external stakeholder input.
- Oversee development of clinical study protocols/amendments, investigator brochures, and clinical study reports.
- Provide input to or lead regulatory interactions and documents (briefing documents, presentations, question responses).
- Provide medical monitoring and safety oversight for study participants.
- Serve as clinical lead for a study (Study Leadership Team) and clinical point of contact for Clinical Matrix Team; partner with internal/external experts.
- Contribute to global regulatory submissions (IND, NDA, BLA, MAA) and regulatory responses.
- Evaluate business development activities (due diligence) and help implement clinical development initiatives using innovative/digital tools.
- Stay current on therapeutic area research, clinical trial methods, competitive/regulatory landscape.
Qualifications:
- Required: Degree in Nursing or Medical related field; experience in clinical research and drug development, including respiratory disease experience.
- Preferred: Medical degree with pulmonary/respiratory specialty training and board qualification/registration; global pharma/biotech respiratory experience; lead global trials and contribute to NDA/BLA/MAA; late-stage respiratory (Phase 2/3) trial design/initiation/execution/closure.
Compensation/Benefits (as stated): US base salary ranges $178,200–$297,000 (certain locations) or $162,000–$270,000 (other US); annual bonus; share-based long-term incentive eligibility; health/insurance, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.