Description
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.
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. You will report to the Clinical Development Lead.
Responsibilities:
- Contribute to project team discussions on indication planning and incorporate input from across disciplines to support vital deliverables.
- Provide effective support to the development and execution of the Integrated Evidence Strategy (IES).
- Design and execute clinical development plans across advanced stages of development.
- Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols.
- Input to, and may lead, regulatory interactions and documents.
- Provide medical monitoring and oversight of the safety of study participants.
- Act as clinical lead for a clinical study.
- Make significant contributions to global regulatory submissions/files.
- Evaluate specific business development activities.
- Stay abreast of advancements in therapeutic area research.
Requirements:
- 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 working in the pharmaceutical industry in clinical drug development.
- Direct experience with in-stream medical oversight activities during trial conduct.
- Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.
Preferred Qualifications:
- Medical degree plus completion of advanced clinical specialty training with board qualification/registration in Hepatology.
- Familiarity or experience in MASH or ALD drug development.
- Clinical research experience in hepatology.
- Experience with site-facing interactions.
- Demonstrated ability to lead line or matrix teams.
- Experience engaging with regulators, payors, and prescribers.
Benefits:
- Annual base salary ranging $222,750 to $371,250.
- Annual bonus and eligibility to participate in share-based long-term incentive program.
- Health care and other insurance benefits.
- Retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.