Therapeutic Area Head, Late-Stage Oncology, GU and Melanoma
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Job Description The Genitourinary and Melanoma Vice President is responsible and accountable for the overarching late-stage development plan for our company's assets in these disease areas. The Vice President (VP) will also be responsible and accountable for the end-to-end lifecycle management of selected assets. The VP will lead their teams to optimize development of assets for the treatment of specific disease areas that they oversee. This individual will ensure technical excellence in their disease areas through the recruitment, management of and guidance of section head(s) and PDT (Product development team) leads. As a key member of the Oncology Clinical Development Leadership Team (OLT), this individual's primary objectives are: Lead the Genitourinary (GU) and Melanoma Clinical Research groups and act as the Therapeutic Area Head for mid to late-stage clinical development for these disease areas. Lead programs for selected assets from early-stage transition into late-stage design/execution for GU malignancies and melanoma. In addition, the VP will be responsible for the end-to-end lifecycle management for selected assets with a GU or melanoma focus that also could have potential across several diseases. Create, develop and implement a successful disease area strategy that will bring forth programs to successful approval, registration and access for the selected indications. Ensures clinical programs and clinical studies are designed and monitored optimally. Ensures that team documents (protocols, governance documents, regulatory documents, external communications, publications, etc) are of the highest quality. Interfaces with functional leaders within Research and Development (R&D) (e.g., Discovery, Translational Biomarkers, GCTO, BARDS, GRACS, TPharm), CORE, Global Human Health, and Manufacturing to ensure optimal decision-making and operational excellence in the leadership of teams. Builds relationships with and gains insights from scientific leaders and key stakeholders in a dynamic and thoughtful way. Contributes to business development by identifying and assessing new assets and leads clinical activities and strategy for assets under consideration. Primary Responsibilities: The GU and Melanoma VP is responsible for the development and implementation of a cross-product development strategy for assets that transition from early to late development space, including both internal compounds, as well as in licensed molecules and those brought in by way of acquisitions. Lead teams of direct and indirect reports who will design, execute, analyze, register and publish results from phase II-III clinical trials. These teams work cross functionally in a matrixed environment, and the VP will ensure clear clinical direction is implemented across programs. Chair DRC committees ensuring optimized protocol design of phase 2 and phase 3 studies. Lead and develop the knowledge/ skills of individuals in their group focusing not only on the "what" is being accomplished but also the "how" their leaders and teams are working. It is expected that there is a focus on quality of execution, cross functional collaboration, as well as growth of teams. The leader should have a track record of and passion for developing individuals for both in-role technical skills as well as overall career development For selected partnered compounds, the VP serves as our company's senior representative on joint development committees with partners. The VP should keep abreast of changing scientific and therapeutic advances, working with discovery/research; early development and business development to ensure identification and movement of key assets for the selected disease areas. Professional Experience and Requirements: M.D., with significant expertise in Medical Oncology, with at least 15 years of relevant academic and/or industry experience including building and leading effective teams. Adult oncology specialty training (oncology fellowship or equivalent) is preferred. A recognized expert in specialty & clinical research, demonstrating depth and breadth of knowledge and understanding of scientific, medical, and regulatory environments, practices and requirements. Skilled in leveraging your expert knowledge for scientific, technical, clinical and regulatory strategic thinking, problem solving and decision making in the evolving pharmaceutical environment. Demonstrated ability to lead and inspire teams and allocate resource strategically and according to portfolio priorities, attracting, retaining, engaging and developing talent in your groups. Energized by delivering high standards through collaboration and motivating others across the organization. Experience with leading regulatory submissions, new trial designs and health authority interactions, development of multiple assets with differing MOAs. The leader should have a broad understanding commiserate for their level regarding the business of development including
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