Woodcliff Lake, NJ, United States
May 28, 2020
Sep 10, 2020
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai s human health care (hhc) mission. We re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Precision Medicine Group of Translational Science department in Eisai s Oncology Business Group is seeking a Senior Director to drive the development of biomarker/companion diagnostic strategies and protocol and to direct all of the analysis process of biomarker data from non-clinical experiments through clinical translational studies for candidate molecules in collaboration with clinical and bioinformatics team in the Oncology Business group. The Senior Director will drive the development of companion diagnostics essential for the safe and effective use of Eisai Oncology Business Group products (most immediately, for Lenvatinib/Keytruda combination and E7090). The Senior Director must be capable of effectively leading International Project Teams (IPT). This role will ensure that the efforts of the Translational Science Group in US and the Biomarker Research Group in Japan are mutually supportive and aligned to ensure efficient development of clinical drug candidates. The candidate should be familiar with multi-parameter profiling (omics) approaches and will be expected to apply innovative and analytical thinking to biomarker discovery and reverse translation approaches to support drug development. The position is office/computer based (not laboratory-based) and the candidate will interact regularly, credibly and effectively with pre-clinical scientists, contract research labs, outside scientists and clinicians. The candidate will work both independently and in a cooperative team-based environment across the broad portfolio of small and large molecule drugs in development within the Oncology Business Group with the goal of providing a high quality dataset to permit effective early phase decisions to be made for each compound in development by the Eisai Oncology Business GroupKey Responsibilities:1. Biomarker and Translational Medicine support to projects in the Oncology Business Group to permit effective IPT development decisions to be made. * Attend IPT team as a IPT representative or extended-members * Develop and review the clinical biomarker and companion diagnostic strategy and protocol. * Clinical biomarker/companion diagnostic management * Clinical biomarker/companion diagnostic operation * KOL/CRO/Vendor communication * Biomarker analysis * Contribution of any documents in study team 2. Drives Development results by assuming leadership of International Project Teams. Lead program project teams to deliver agreed objectives related to quality, time and cost including the following: * Defines project vision and strategy for achieving that vision, and engages and motivates team to buy into vision and execute strategy through clear and persuasive communication skills * Leads problem solving across the projects: facilitating team(s) to identify issues and propose solutions * Collaboration within Eisai (including cross-functional project teams) as well as with Eisai s business partners including other pharmaceutical firms, vendors (eg, companion diagnostic providers), and academic research groups 3. Contribute to Development results by providing project leadership and assuming a supervisory and/or subject matter expert role with regard to project issues. 4. Bring external market perspectives and shares insight and knowledge regarding therapeutic areas with groups within own department and across Eisai as appropriate 5. Lead clinical study teams to deliver agreed objectives related to quality, time and cost 6. Lead Biomarker and companion diagnostic team including the following: * Ensure that the group has information required to achieve the group s business objectives * Provide technical insight as needed to ensure progress towards goals * Contribute innovative thinking and brings an external market perspective to task execution * Engender trust and respect from direct reports, peers, colleagues and senior leaders across Eisai by communicating openly and honestly * Motivate exceptional performanceJob Requirements: * MD or PhD in related field * 10-15 years of Medical and/or technical development expertise within a major therapeutic area with significant industry and/or academic experience * Specific experience of Biomarker and Companion Diagnostic in the oncology therapeutic area * Significant experience of leading clinical trials and clinical study teams * Demonstrated ability to work with cross functional teams and working knowledge of other functional areas (e.g., clinical operations, pharmacology, pharmacokinetics, regulatory, pre-clinical and marketing) Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation
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