Medical Director, Clinical Development, Hepatology
GSK
8 hours ago
Remote friendly (Central, PA)
United States
Clinical Research and Development
Position Summary:
A Medical Director, Clinical Development, Hepatology to provide clinical and scientific insights for new, established and emerging assets in clinical development with a strong focus on liver diseases. Work within project teams to plan, execute, and deliver clinical development activities up to and including registrational studies. Reports to the Clinical Development Lead.
Responsibilities:
- Contribute to project team discussions on indication planning; incorporate input from scientific, clinical, commercial, regulatory, stats and other disciplines to support deliverables (TPP, CDP, study protocols, IES and planning).
- Support development and execution of the IES, including oversight of R&D evidence generation to ensure patient safety and study delivery.
- Design and execute clinical development plans in advanced stages, reflecting internal/external stakeholder input (patients, evidence generation, regulators, payors, pharmacovigilance, etc.).
- Oversee development of clinical study protocols, amendments, investigator brochures, and clinical study reports to support clinical timelines.
- Provide input to, and may lead, regulatory interactions and documents (briefing documents, presentations, and responses to regulatory questions).
- Provide medical monitoring and safety oversight for study participants (with Pharmacovigilance Physician); if physician, ensure Medical Governance and scientific integrity.
- Act as clinical lead for a clinical study; key role on SLT and clinical point of contact for the study within the CMT and with external experts (regulators, payors, CROs, consultants, investigators).
- Contribute to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA).
- Evaluate business development activities (due diligence) and support implementation of strategic/organizational Clinical Development initiatives using innovative/digital methodologies.
- Stay abreast of therapeutic area research, clinical trial methodologies, competitive environment, and regulatory landscape.
Additional Responsibilities:
- Adapt to changing environments; analyze incomplete information, identify risks, and make informed decisions.
- Collaborate across the matrix; integrate cross-functional knowledge and balance team and business goals.
- Generate innovative improvement ideas; manage conflicts and negotiate mutually acceptable solutions.
- Analyze/interpret/critically evaluate complex data, information, and digital content to anticipate obstacles and propose solutions.
- Achieve outcomes through strong influencing skills, building trust and tailoring communication.
Basic Qualifications (Required):
- Medical degree.
- Clinical medical specialty training with board qualification/registration in Internal Medicine or Primary Care/Family Medicine.
- Completion of a full clinical residency program leading to board qualification/certification.
- Pharmaceutical industry experience in clinical drug development; understanding clinical trial execution from concept to publication.
- Direct experience with in-stream medical oversight during trial conduct.
- Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.
- Understanding of clinical research methodology and biostatistical principles for trial design and data-driven decisions.
Preferred Qualifications (Plus):
- Advanced specialty training with board qualification/registration in Hepatology (or equivalent).
- Familiarity/experience in MASH or ALD drug development; disease biology and therapeutic targets/treatment landscape.
- Clinical research experience in hepatology, including clinical development planning and interventional study design.
- Site-facing interactions and/or support for medical affairs, patient advocacy groups, or external organizations.
- Ability to lead line or matrix teams and inspire high performance.
- Experience engaging regulators, payors, and prescribers in relevant markets.
- Experience integrating genetic data to inform clinical protocols.
- Ability to apply statistics and data visualization to interpret complex information and support decisions.
- Experience using new digital tools and learning technologies to drive innovation.
How to apply:
- Apply with your CV and a short note describing a clinical development project you led and the impact it delivered.
A Medical Director, Clinical Development, Hepatology to provide clinical and scientific insights for new, established and emerging assets in clinical development with a strong focus on liver diseases. Work within project teams to plan, execute, and deliver clinical development activities up to and including registrational studies. Reports to the Clinical Development Lead.
Responsibilities:
- Contribute to project team discussions on indication planning; incorporate input from scientific, clinical, commercial, regulatory, stats and other disciplines to support deliverables (TPP, CDP, study protocols, IES and planning).
- Support development and execution of the IES, including oversight of R&D evidence generation to ensure patient safety and study delivery.
- Design and execute clinical development plans in advanced stages, reflecting internal/external stakeholder input (patients, evidence generation, regulators, payors, pharmacovigilance, etc.).
- Oversee development of clinical study protocols, amendments, investigator brochures, and clinical study reports to support clinical timelines.
- Provide input to, and may lead, regulatory interactions and documents (briefing documents, presentations, and responses to regulatory questions).
- Provide medical monitoring and safety oversight for study participants (with Pharmacovigilance Physician); if physician, ensure Medical Governance and scientific integrity.
- Act as clinical lead for a clinical study; key role on SLT and clinical point of contact for the study within the CMT and with external experts (regulators, payors, CROs, consultants, investigators).
- Contribute to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA).
- Evaluate business development activities (due diligence) and support implementation of strategic/organizational Clinical Development initiatives using innovative/digital methodologies.
- Stay abreast of therapeutic area research, clinical trial methodologies, competitive environment, and regulatory landscape.
Additional Responsibilities:
- Adapt to changing environments; analyze incomplete information, identify risks, and make informed decisions.
- Collaborate across the matrix; integrate cross-functional knowledge and balance team and business goals.
- Generate innovative improvement ideas; manage conflicts and negotiate mutually acceptable solutions.
- Analyze/interpret/critically evaluate complex data, information, and digital content to anticipate obstacles and propose solutions.
- Achieve outcomes through strong influencing skills, building trust and tailoring communication.
Basic Qualifications (Required):
- Medical degree.
- Clinical medical specialty training with board qualification/registration in Internal Medicine or Primary Care/Family Medicine.
- Completion of a full clinical residency program leading to board qualification/certification.
- Pharmaceutical industry experience in clinical drug development; understanding clinical trial execution from concept to publication.
- Direct experience with in-stream medical oversight during trial conduct.
- Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.
- Understanding of clinical research methodology and biostatistical principles for trial design and data-driven decisions.
Preferred Qualifications (Plus):
- Advanced specialty training with board qualification/registration in Hepatology (or equivalent).
- Familiarity/experience in MASH or ALD drug development; disease biology and therapeutic targets/treatment landscape.
- Clinical research experience in hepatology, including clinical development planning and interventional study design.
- Site-facing interactions and/or support for medical affairs, patient advocacy groups, or external organizations.
- Ability to lead line or matrix teams and inspire high performance.
- Experience engaging regulators, payors, and prescribers in relevant markets.
- Experience integrating genetic data to inform clinical protocols.
- Ability to apply statistics and data visualization to interpret complex information and support decisions.
- Experience using new digital tools and learning technologies to drive innovation.
How to apply:
- Apply with your CV and a short note describing a clinical development project you led and the impact it delivered.