Medical Director- Oncology Clinical Development

vor 3 Wochen

Zug, Schweiz GSK Vollzeit

**Site Name**: USA - Massachusetts - Waltham, Switzerland - Zug, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence

**Posted Date**: Mar 28 2023

Are you an Oncology clinical research physician with an interest to expand your reach for improving patients' lives who have cancer with a company emerging with innovative medicines? If so, this Medical Director opportunity may be of interest to you.

**GSK ONCOLOGY**

Our Oncology R&D organization is building a diverse portfolio of Oncology medicines, focused on maximizing patient survival through transformation medicines. We aim to deliver first-to-market and first-in-class solutions that have the potential to address some of the biggest challenges in oncology.

Our organization covers the entire research and development spectrum from discovery to clinical development and regulatory compliance. We partner with other R&D functions, including Commercial and Medical to build our pipeline, manage trials, and progress from development to commercialization. We also pursue and manage critical business development opportunities, collaborations and acquisitions to advance our mission.

GSK continues to be committed to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer:

- Immuno-Oncology - Focused on an innovative pipeline of immune modulators designed to leverage a patient’s immune system to recognize and eradicate solid and liquid tumors.
- Tumor Cell Targeting - Target tumor-specific alterations to introduce selective anti-cancer activity.
- Synthetic Lethality **- **Optimizing the use of PARP-inhibitors and delivering a Repertoire of Synthetic Lethal Medicines.

For more information please visit:
The Medical Director Oncology Clinical Development will report to the Group Sr. 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 in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts.

This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

**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 including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and medical data review.
- 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 a

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