GSK

Medical Director- Oncology Clinical Development (Cell and Gene Therapy Team)

Employer
GSK
Location
Waltham, Massachusetts; Collegeville, Pennsylvania
Salary
Competitive
Posted
November 19 2020
Ref
271982
Organization Type
Pharma
Are you interested in a highly visible oncology clinical development role in the exciting platform of cell and gene therapy with a premier company focused in oncology R & D? If so, this Medical Director position is an ideal opportunity to explore.

GSK ONCOLOGY:

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

R&D collaboration with Lyell Immunopharma to develop next generation cancer cell and gene therapies:
  • GSK announced a collaboration with Lyell Immunopharma, a San Francisco biotechnology company, in late 2019 to develop new technologies to improve cell therapies for cancer patients. The collaboration will apply Lyell's technologies to further strengthen GSK's cell therapy pipeline, including GSK3377794, which targets the NY-ESO-1 antigen that is expressed across multiple cancer types. To date, two cell therapies have been approved for blood-borne cancers, but engineered T cells have not yet delivered strong clinical activity in common solid tumors. Lyell is exploring several approaches to improving T cell function and increasing T cell “fitness” to enhance initial response rates in solid tumor cancers and to prevent relapses due to loss of T cell functionality. Combining GSK's strong cell and gene therapy programs with Lyell's technologies may allow us to maximize the activity and specificity of cell therapies in solid tumor cancers, where there is a high unmet medical need.
  • The collaboration also builds on GSK's world-leading manufacturing platform and expertise for cell and gene therapy that delivered the world's first approved ex vivo gene therapy (Strimvelis) for ADA-SCID in 2016.




OVERVIEW:

The Cell and Gene Therapy (CGT) Team at GSK is seeking a talented physician-scientist to lead one of the TCR T cell therapy programs in solid tumors. The CGTTeam oversees a broad cellular therapy 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, Medical Director- Oncology Clinical Development (Cell and Gene Therapy Team)
  • 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?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • M.D. (or equivalent) with board certification or board qualifications in Medical Oncology or Hematology/Oncology. US State Licensure to practice medicine is desirable.
  • At least 3 years of 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


Preferred Qualifications:
  • M.D./Ph.D. a plus
  • Cell therapy and/or bone marrow transplant experience preferred
  • Strong knowledge of immunology preferred.


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, rigor and risk, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritization, execution, delivering performance.
  • Setting strategic direction and leading on-going organizational transformation.
  • Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization 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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