Medical Director-Oncology Clinical Development - ICOS INDUCE-4
- Waltham, MA
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Jun 29 2020
Do you want to be part of a highly regarded Oncology R & D organization and team focused on improving cancer patients' lives? If so, this Medical Director position in Oncology Clinical Development is a career opportunity to consider.
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
GSK's Oncology Transformation at a Glance : https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001
ASCO 2020: https://us.gsk.com/en-us/gsk-at-asco-2020/
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 in the development and execution of clinical trials from start to finish.Contribute to ongoing or planned interventional clinical trials (Phases I, II, or III)
- In collaboration with clinical teams, drive clinical trial execution to achieve timely completion 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.
- 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.
- Minimum: MD (or equivalent) with completed training in a medical specialty. US State Medical license to practice medicine is desirable.
- Preferred: 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 and 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 medical oncology. Strong credibility within the US medical community which includes the ability to reach out to key thought leaders in academia.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- 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
About GSK Oncology
GSK Oncology is committed to the discovery and development of new and potentially life-changing therapies for patients with cancer. Our vision is for people with cancer to not only to live, but to live well, because we are delivering innovative and transformational medicines. We have strictly focused our portfolio on innovation with a focus on the leading edges of science: immuno-oncology, cell therapy and epigenetics. Our deep insight into cancer biology coupled with strategic partnerships will allow us to develop synergistic combinations with transformational potential.
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