Medical Director - Oncology R & D - Cell & Gene Therapy
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Jun 14 2021 At GSK, we are dedicated to driving the innovative and personalized approach of cell and gene therapy to cancer treatment for solid tumors. Do you want to be part of one of the fastest growing areas in oncology with considerable therapeutic potential? If so, this Medical Director- Oncology Cell and Gene Therapy position 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. 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: Cancer Epigenetics, Immuno-Oncology, Oncology Cell & Gene Therapy and Synthetic Lethality. For more information on these areas of focus, read GSK's Oncology Transformation at a Glance . The Cell and Gene Therapy (CGT) Team at GSK is seeking a talented physician-scientist to join the team supporting the TCR T cell therapy programs in solid tumors. The CGT Team oversees a broad cellular therapy portfolio and drives development from first-time-in-human studies through proof of concept. 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 execution of 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 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 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 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. *LI- GSK Why you? Qualifications: We are seeking a professional with the following qualifications and skills to achieve our goals: Physician-scientist with strong understanding of translational disease biology or ability to design innovative trials based on emerging biomarkers and clinical outcome measures M.D. or M.D./Ph.D. (or ex-US equivalent) with Board Certification in a relevant specialty; oncology or hematology. Experience with cell therapy or bone marrow transplant a plus but not required. Background in immunology a plus At least 3 years of oncology clinical research experience required with experience within the pharmaceutical or biotechnology industry preferred, or a strong track record of experience with leading oncology clinical trials in an academic research setting. 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. Good communication and collaborative skills with experience at working with cross-functional and external groups, including researchers, clinicians and other stakeholders 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, rigor and risk Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Translating strategy into action - a compelling narrative, motivating others, setting objectives. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Leadership (expertise, self-awareness, high performance behaviors and ability to execute the assigned role) in a matrix and line environment Embedding a culture of individual empowerment across the broader study team 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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