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Medical Director, Clinical Development
October 13, 2017 - November 14, 2017
• M.D. degree with sub-specialty in Oncology and clinical development experience is highly preferred
• 5 years pharmaceutical or relevant medical/clinical experience
• Keen understanding of drug development
• Experience with clinical and translational investigation of cell-based therapy, cancer immunotherapies and/or cancer epigenetics modifiers is a plus.
• Relevant experience in early phase drug development and translational medicine is an advantage
• Demonstrated track record of successfully developing and executing Clinical Development Plans
• Proven ability to strategize, prioritize, and manage multiple projects simultaneously to ensure quality, timely, on-target and within budget accomplishment of tasks.
• Managerial experience with demonstrated track record of successfully managing high-performance cross-functional matrix teams in a complex organization with minimal direct supervision.
• Ability to embed medical functional skills and strategic thinking into teams
• Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement
Vision and strategy: a passion to develop novel therapeutics for cancer patients. A deep understanding of areas of unmet clinical need and the ability to integrate this with the drug development activities required to advance compounds to POC and registration trials. Understanding of technical aspects relevant to early drug development in the pharmaceutical industry including knowledge of GCP, regulatory processes (US and International) is highly desirable. Experience working collaboratively with key external oncology experts is required.
Leadership: Ability to implement the clinical vision and strategy. To lead intra- and inter-departmental teams, matrix-manage a cross-functional team with integrity, flexibility and forthright communication. This requires exceptional interpersonal skills and the ability to meet project objectives by influencing and motivating key partners. Demonstrated alignment with and commitment to GSK Oncology vision and goals.
Judgment: evidence of good clinical and scientific judgment. Ability to interpret the significance of preclinical and clinical data, and to anticipate the information that will be needed to satisfy regulatory requirements for early and late phase oncology studies. Ability to progress projects safely and efficiently. Know when to seek advice from colleagues and senior management.
Teamwork: build and lead clinical development teams and determine what resources and talents are needed for the rapid progression of the projects. Interact effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills. Able to secure, manage and maintain critical partnerships with key business partners.
Collaborate: form collaborations with key external experts to take world class science and deliver meaningful benefits for patients.
The Medical Director is accountable for the clinical development of one or more assets in Immuno-Oncology (IO), Oncology Cell Therapy (OCT), and Cancer Epigenetics (CE). These three Discovery Performance Units (DPUs) focus on developing innovative therapeutics for treating various oncologic and hematologic indications.
In IO, anti-BCMA antibody-drug conjugate has demonstrated unprecedented efficacy (~60% overall response rate) in refractory/relapsed multiple myeloma. Other IO assets include the first-in-class anti-ICOS agonist antibody, anti-OX-40 agonist antibody, TLR4 agonist, and multiple near clinical stage assets.
In OCT, GSK recently excised the early opt-in option for an investigational NY-ESO-1 TCR-modified T cell therapy from AdaptImmune. This novel cell therapy delivered a 50% ORR in synovial sarcoma, and it being investigated in multiple other solid tumors.
The CE clinical pipeline includes multiple clinical stage assets including BET, LSD1, and PRMT5 inhibitors.
The candidate will be responsible for leading clinical development team(s) consisting of physicians, clinical scientists and other function representatives, strategizing development plan, executing clinical trials, and managing the development resources and timeline. This role requires a cross-matrix senior leader to drive an integrated strategy across different indications for each responsible asset, and to establish combination strategies with various internal and external assets.
Immuno-Oncology, Oncology Cell Therapy, and Cancer Epigenetics are the three strategic research areas of GSK Oncology R&D.
• GSK Immuno-Oncology is exploring the utility of 4 different modalities in augmenting host anti-cancer immunity —monoclonal antibodies (mAbs), bi-specific antibodies, small molecules, and cellular therapies. The anti-BCMA antibody-drug conjugate has demonstrated unprecedented efficacy (~60% overall response rate) in refractory/relapsed multiple myeloma. Other lead assets in Immuno-Oncology include the first-in-class anti-ICOS agonist antibody, anti-OX-40 (CD134) agonist antibody, and TLR4 agonist.
• The newly established OCT Discovery Performance Unit (DPU) is focusing on developing cell-based therapeutics for treating various oncologic and hematologic indications. GSK recently excised the early opt-in option for an investigational NY-ESO-1 TCR-modified T cell therapy from AdaptImmune. This novel cell therapy delivered a 50% ORR in synovial sarcoma, and it being investigated in multiple other solid tumors. The asset was designated as Breakthrough Therapy by the US FDA, as well as PRIME status by EMA.
• GSK Cancer Epigenetics develops drug to modulate chromatin and DNA to modulate broad gene expression and treat cancer, and has one of the most extensive clinical stage pipeline in cancer epigenetics including inhibitors of BET, LSD1, and PRMT5. In addition, there are 2 near clinical stage assets in Cancer Epigenetics portfolio.
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 these assets are completing early phase development and transitioning into pivotal trial stage, this is an exciting opportunity to be instrumental in the success of these assets and benefit cancer patients.
The Medical Director Oncology will be a senior leader who will lead clinical development teams consisting of physicians, clinical scientists, as well as other function area representatives thus being accountable for the clinical development of investigational anti-cancer agents from FTIH to POC and registration. This person may also be responsible for providing medical guidance for activities from Candidate Selection through to POC and registration, and will require accountability for the provision of design and medical governance for early phase and pivotal clinical studies; development of high quality clinical plans and data analysis strategies that encompass appropriate imaging, biomarkers, surrogate endpoints, and enabling technologies. An essential component of the roles is the building and maintenance of effective business partnerships within GSK Oncology R &D and with external partners and collaborators. Strong self-motivation and perseverance are desired.
Please use the cover letter to highlight how you meet the qualifications and competencies for the role. Your CV along with your cover letter will be used to assess your application.