Position Summary
A Medical Director, Clinical Development, Hepatology is sought to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on liver diseases. You will work within project teams to plan, execute, and deliver clinical development activities up to and including registrational studies. This role is pivotal in driving GSK’s mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency.
Responsibilities
* Contribute to project team discussions on indication planning and incorporate input from across disciplines to support deliverables including TPP, CDP, study protocols, and integrated evidence strategy.
* Support the development and execution of the Integrated Evidence Strategy, ensuring patient safety and study delivery.
* Design and execute clinical development plans across advanced stages of development, reflecting internal and external stakeholder input.
* Contribute to ambitious clinical development timelines by overseeing the development of study protocols, amendments, investigator brochures, clinical study reports, etc.
* Lead regulatory interactions and documents, including briefing documents, presentations, and responses for assigned studies and programs.
* Provide medical monitoring and oversight of participant safety, in partnership with Pharmacovigilance.
* Act as clinical lead for a clinical study, serving as clinical point of contact on the Clinical Matrix Team.
* Make contributions to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA).
* Evaluate business development activities, including due diligence and implementing strategic initiatives in Clinical Development.
* Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space.
Additional Responsibilities
* Demonstrate flexibility and adaptability in changing environments, making informed decisions on incomplete information.
* Integrate cross‑functional knowledge in decision‑making processes and balance team objectives with business goals.
* Generate ideas for innovative improvement and promote creative environments.
* Manage conflicts effectively, negotiating mutually acceptable solutions.
* Critically evaluate data, information, and digital content to anticipate obstacles and identify solutions.
* Achieve desired outcomes through strong influencing skills and persuasive communication.
Basic Qualifications
* 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.
* Experience in the pharmaceutical industry in clinical drug development, with understanding of 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 to support innovative and efficient trial design.
Preferred Qualifications
* Medical degree plus advanced clinical specialty training in Hepatology (or equivalent).
* Familiarity with MASH or ALD drug development and current treatment landscape.
* Clinical research experience in hepatology, including interventional study design.
* Experience with site‑facing interactions supporting medical affairs or patient advocacy.
* Demonstrated leadership of line or matrix teams with a strong reputation for inspiring performance.
* Experience engaging regulators, payors, and prescribers in relevant markets.
* Experience integrating genetic data into clinical protocols.
* Proven ability to apply statistical and data visualization methods for decision‑making.
* Experience using digital tools and learning technologies to drive innovation.
Salary and Benefits
The annual base salary for new hires ranges from $222,750 to $371,250 for positions based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA. For other U.S. locations the range is $202,500 to $337,500. In addition to base salary, this position offers an annual bonus and eligibility to participate in GSK’s share‑based long‑term incentive program. Benefits include health care and other insurance benefits for employees and families; retirement benefits; paid holidays, vacation, and paid caregiver/parental and medical leave.
EEO Statement
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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