Medical Director
3 weeks ago
Are you a pharma physician or academic clinician looking to contribute to GSK's growing oncology antibody drug conjugate (ADC) portfolio for the treatment of solid tumors in GI, GU and beyond? This position is a great opportunity to be part of a dynamic team.
The PositionThe Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders so as to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts.
Key Responsibilities- Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
- Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
- Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
- Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
- Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
- Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs.
- Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
- Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
- Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
- Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.
- Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
- Serve as a core member of the Clinical Matrix Team for one or more assets in development.
- Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
- Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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