Medical Director- Oncology Clinical Development - Niraparib, Open to flexible working
1 day left
- Contract Type
Do you want to be part of a highly regarded and rapidly growing Oncology R&D team focused on improving the lives of cancer patients? If so, the Medical Director supporting Niraparib is an excellent opportunity to explore.
GSK is expanding the Oncology Clinical Development organization and we are seeking experienced professionals to join our exciting journey to further build and execute. GSK Oncology has a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer, specifically in four areas of cancer research:
- 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 development and execute 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 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.
We are seeking a professional with the following qualifications and skills to achieve our goals:
- MD (or equivalent) with board certification or board qualifications in medical oncology or other related oncology-subspecialty ( surgical, gynecologic, radiation)
- 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.
Our values and expectations are 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.
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, colour, 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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