The Medical Director as a study physician 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 Opinion Leaders.
- Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others as necessary to development and execution of clinical trials from beginning to end. Contribute to ongoing or planned interventional clinical trials (phase 1-3)
- In collaboration with clinical teams, drive clinical trial execution to achieve timely completion and to ensure scientific integrity of clinical studies.
- Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review.
- Conduct safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies.
- Analysis, interpretation and presentation of clinical study data.
- Participate in authoring of regulatory documents and Collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
- Participate in clinical study report writing and review, using medical expertise to identify ways to best analyze and present data
- 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.
- Represent GSK at medical meetings, advisory boards and outreach meetings as needed/appropriate.
We are looking for professionals with these required skills to achieve our goals:
- MD (or equivalent) with board certification or board qualifications in medical oncology.
- At least 3 years of clinical development experience within the pharmaceutical or biotechnology industry with focus and strong track record of experience with leading oncology clinical trials.
- Strong working knowledge of the clinical drug development process Track record in the conduct/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
- Successful academic research publication history or history of medical practice in a relevant field.
- US State Licensure to practice medicine is desirable.
- Solid personal and professional relationships with key opinion leaders (KOLs) in medical oncology. Strong credibility within the US medical community which includes the ability to reach out to key thought leaders in academia.