Medical Director- Oncology Clinical Development - BCMA

GSK oncology is committed to the discovery and development of new oncology therapies that leverage patient-driven science to deliver improved outcomes for more patients. Are you keen to take your career to a level of recognition and greatest impact on a leading oncology asset at GSK? Then this Medical Director-Oncology Clinical Development position supporting BCMA on the Immuno-Oncology team is one to consider.

Why you?

GSK is expanding its Oncology organization, and we are looking for experienced professionals to help us rebuild and grow our internal expertise! We have an exciting (and expanding) portfolio, and are looking for a Medical Director to transform delivery of our Oncology clinical studies. It's a wonderful time to join our team as wediscover and develop new oncology therapies with the life-changing potential of helping patients with cancer, specifically in three areas of cancer research: Cancer Epigenetics, Immuno-Oncology, Oncology Cell Therapy and Synthetic Lethality.

Within the I-O strategic research area of GSK Oncology R & D, the Medical Director- BCMA is accountable for the clinical development of one the leading Oncology assets in Immuno-Oncology (IO): anti BCMA antibody drug conjugate (ADC), GSK2857916. The candidate will be responsible for leading clinical study team consisting of clinical scientists and other function representatives, strategizing development plan, executing clinical trial(s) in multiple myeloma and related diseases, and managing the development study resources and timeline. This role requires a cross-matrix leader to contribute to an integrated strategy across different indications for GSK'916, and to combination strategies with various internal and external assets.

Clinical Development at GSK is responsible for the development of the oncology portfolio from First Time In Human (FTIH) clinical trials to Proof-of-Concept studies, and pivotal registration trials. As GSK'916 is completing early phase development and transitioning into pivotal trial stage, this is an exciting opportunity to be instrumental in the success of this asset and to provide benefit to cancer patients. Candidate will be accountable for the design of clinical trials, and for medical governance for clinical studies; development of high quality clinical plans and data analysis strategies that encompass appropriate imaging, biomarkers, surrogate endpoints, and enabling technologies.

https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001

\ASCO 202: https://us.gsk.com/en-us/gsk-at-asco-2020/

The Job:

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.

Job Responsibilities:

• 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.

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*LI-GSK

Basic Qualifications:

• 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.
• Academic oncologists with strong clinical and research experience in hematologic malignancies 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.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

US State License to practice medicine is desirable.

Why GSK?

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.
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

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