Medical Director- Oncology Clinical Development- Early ICOS
- Weston, MA
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Oct 19 2020
Does being part of an immuno-oncology clinical research team with a premier pharmaceutical company committed to researching and developing drugs which improve patients lives ? If so, this Oncology R & D Medical Director role could be an ideal opportunity to explore.
GSK's Pharmaceutical Medicines business:
GSK Oncology R&D is focused on building industry-leading portfolios in four cutting-edge areas of science:
•Immuno-Oncology : using the human immune system to treat cancer
• Cell/Gene Therapy: engineering human T-cells to target cancer
•Cancer Epigenetics: modulating the gene-regulatory system of the epigenome to exert anti-cancer effects
•Synthetic Lethality: targeting two mechanisms at the same time which together, but not alone, have substantial effects against cancer
For more Information on GSK Oncology, please visit:
- GSK's Oncology Transformation: https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001
- 2019 Annual Report: https://www.gsk.com/en-gb/investors/corporate-reporting/annual-report-2019
PURPOSE: 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. KEY RESPONSIBILITIES:
- 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 and other functional 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 internal GSK teams and external CRO pharmacovigilance group of active clinical studies.
- Provide ongoing 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.
- MD (or equivalent) with board certification or board qualifications in medical or pediatric or surgical or radiation oncology.
- 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.
- Solid personal and professional relationships with key opinion leaders (KOLs) in the oncology therapeutic community. Strong credibility within the broader US medical community which includes the ability to reach out to key thought leaders in academia.
- Preferable to have 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.
- US State Licensure to practice medicine is desirable
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritisation, execution, delivering performance.
- Setting strategic direction and leading on-going organisational transformation.
- Building a resilient organisation.
- Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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