Medical Director - Oncology Clinical Development - niraparib (new indications)
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham
Posted Date: Oct 23 2020
Does it excite you and have you committed your career next step to be in the forefront of maximizing patient survival through transformational oncology medicines? If so, this Medical Director position is an excellent opportunity to explore.
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
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 develop and execute clinical trials from beginning to end. Contribute to ongoing or planned interventional clinical trials (phase 1-3)
- 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.
- In collaboration with clinical teams, drive clinical trial execution to achieve timely completion and to ensure scientific integrity of clinical studies.
- 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 generation 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.
GSK's Oncology Transformation: https://bit.ly/2zTytwmon https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001
ASCO Highlights/Endorsements: https://www.gsk.com/en-gb/media/press-releases/gsk-highlights-scientific-innovation-and-advances-in-its-growing-oncology-portfolio-at-asco-2020/#
- MD (or equivalent) with board certification or board qualifications in medical oncology. US State License to practice medicine is desirable
- 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. Alternatively, academic professional experience with significant clinical research activity or robust medical affairs background in Oncology will be considered.
- 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 medical oncology. Strong credibility within the US medical community which includes the ability to reach out to key thought leaders in academia.
- Board certification/eligibility, and clinical experience in oncology or hematology/oncology preferred
- A strong professional track record and clinical research experience in colon-rectal, Breast or brain cancer.
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.
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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