Medical Director, Clinical Development, Hepatology
GSK
8 hours ago
On-site
Boston, MA
Clinical Research and Development
Position Summary:
- Provide clinical and scientific insights to potential 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.
Responsibilities:
- Contribute to project team discussions on indication planning; incorporate input across disciplines to support deliverables including TPP, CDP, study protocols, and IES.
- 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 across advanced stages, reflecting internal and external stakeholder input.
- Oversee development of clinical study protocols, amendments, investigator brochures, and clinical study reports to support clinical development timelines.
- Input to, and may lead, regulatory interactions and documents (briefing documents, presentations, and responses to questions).
- Provide medical monitoring and safety oversight on behalf of the Sponsor with the Pharmacovigilance Physician; if a physician, ensure Medical Governance and scientific integrity.
- Act as clinical lead for a clinical study; serve on the Study Leadership Team and as clinical point of contact within the Clinical Matrix Team.
- Contribute to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including document preparation and regulatory question responses.
- Evaluate business development activities (including due diligence) and help embed strategic initiatives in Clinical Development using innovative methodologies and digital tools.
- Stay abreast of therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space.
Additional Responsibilities:
- Demonstrate flexibility/adaptability; analyze incomplete information; identify risks; make informed decisions.
- Collaborate across the matrix; integrate cross-functional knowledge; balance team objectives with business goals.
- Proactively generate ideas for improvement; promote creativity.
- Manage conflicts and negotiate mutually acceptable solutions.
- Analyze and critically evaluate complex data/information/digital content to anticipate obstacles and identify solutions.
- Achieve outcomes through influencing skills and tailored, persuasive 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 or certification.
- Pharmaceutical industry experience in clinical drug development; understanding clinical trial execution from concept to publication.
- Direct experience with in-stream medical oversight activities during trial conduct.
- Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.
- Understanding of clinical research methodology and biostatistical principles for clinical trial design and data-driven decision rules.
Preferred Qualifications:
- Advanced specialty training with board qualification/registration in Hepatology (or equivalent).
- Familiarity/experience in MASH or ALD drug development; disease biology and therapeutic targets.
- Clinical research experience in hepatology, including development planning and interventional study design.
- Experience supporting 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.
- Experience integrating genetic data to inform clinical protocols.
- Ability to apply statistical and data visualization methods to interpret complex information.
- 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 delivered.
Compensation/Benefits (explicitly stated):
- Annual base salary (US): $222,750–$371,250 for Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA; or $202,500–$337,500 for other US locations.
- Annual bonus; eligibility for share-based long-term incentive; benefits include health care/insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.
- Provide clinical and scientific insights to potential 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.
Responsibilities:
- Contribute to project team discussions on indication planning; incorporate input across disciplines to support deliverables including TPP, CDP, study protocols, and IES.
- 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 across advanced stages, reflecting internal and external stakeholder input.
- Oversee development of clinical study protocols, amendments, investigator brochures, and clinical study reports to support clinical development timelines.
- Input to, and may lead, regulatory interactions and documents (briefing documents, presentations, and responses to questions).
- Provide medical monitoring and safety oversight on behalf of the Sponsor with the Pharmacovigilance Physician; if a physician, ensure Medical Governance and scientific integrity.
- Act as clinical lead for a clinical study; serve on the Study Leadership Team and as clinical point of contact within the Clinical Matrix Team.
- Contribute to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including document preparation and regulatory question responses.
- Evaluate business development activities (including due diligence) and help embed strategic initiatives in Clinical Development using innovative methodologies and digital tools.
- Stay abreast of therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space.
Additional Responsibilities:
- Demonstrate flexibility/adaptability; analyze incomplete information; identify risks; make informed decisions.
- Collaborate across the matrix; integrate cross-functional knowledge; balance team objectives with business goals.
- Proactively generate ideas for improvement; promote creativity.
- Manage conflicts and negotiate mutually acceptable solutions.
- Analyze and critically evaluate complex data/information/digital content to anticipate obstacles and identify solutions.
- Achieve outcomes through influencing skills and tailored, persuasive 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 or certification.
- Pharmaceutical industry experience in clinical drug development; understanding clinical trial execution from concept to publication.
- Direct experience with in-stream medical oversight activities during trial conduct.
- Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.
- Understanding of clinical research methodology and biostatistical principles for clinical trial design and data-driven decision rules.
Preferred Qualifications:
- Advanced specialty training with board qualification/registration in Hepatology (or equivalent).
- Familiarity/experience in MASH or ALD drug development; disease biology and therapeutic targets.
- Clinical research experience in hepatology, including development planning and interventional study design.
- Experience supporting 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.
- Experience integrating genetic data to inform clinical protocols.
- Ability to apply statistical and data visualization methods to interpret complex information.
- 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 delivered.
Compensation/Benefits (explicitly stated):
- Annual base salary (US): $222,750–$371,250 for Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA; or $202,500–$337,500 for other US locations.
- Annual bonus; eligibility for share-based long-term incentive; benefits include health care/insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.