Clinical Research and Development Corporate Vice P job in Summit, NJ| Recruit Arrow
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Clinical Research and Development Corporate Vice P
Location : New Jersey, Summit
Refer job # FDMG338189
Job Responsibilities and Requirements: RESPONSIBILITIES: The VP or Corporate Vice President will lead or participate in and have critical input into leading, overseeing and partnering on all of the clinical elements of development for multiple medical/clinical programs around the world. He/she will be responsible for driving the implementation of the overall medical/clinical strategic direction for the MDS/AML team. The major responsibilities of the VP or Corporate Vice President will be to: Lead the CR&D Therapeutic Area team, attract, retain and develop talent for all roles in the team, be responsible for engagement and collaboration across the team Drive indication and product strategic vision through strong scientific and medical knowledge, exceptional understanding of the drug development process and a strong ability to contribute/lead cross-functional teams. Active membership of the cross-functional Oncology Leadership Meeting (OLM) and the department-internal CR&D Leadership Team Active membership and functional leadership in the cross-functional Disease Strategy Team for MDS/AML, ability to lead such a team Incorporate a sound business sense into the clinical development program Very close collaboration and partnership with Regulatory Affairs to drive clinical strategic objectives, submissions and approvals Medical/clinical review on due diligence and in-licensing opportunities Build efficiency and innovation into the clinical development program and look for innovative ways to do clinical trials - like biomarker strategy Understand how all clinical development groups work together and how it all funnels into clinical data flow. Take a role within the global CR&D leadership team in order to advance the work of the whole department Organize and lead advisory boards and investigator meetings relevant to clinical projects with the respective teams in the therapeutic area. Responsible as a thought leader in the development of new and innovative strategies related to regulatory and clinical use of new and existent pharmaceuticals Responsible for clinical budget allocations, capacity planning and responsibility for utilization reporting and budget review and tracking Develop strong and reliable relationship to Celgene's partners in the joint development of medicines for this therapeutic area. QUALIFICATIONS PREREQUISITES: Physician (MD or equivalent) with 10-15 years of pharma or biotech experience in Hematology or Oncology SKILLS: The VP or CVP must be a physician (MD or equivalent, academic experience/credentials a plus but not essential) with 10-15 years of pharma or biotech experience in Hematology or Oncology as well as sufficient clinical experience in the treatment of MDS and AML (preferably) or other hematological malignancies in Celgene's portfolio (esp. multiple myeloma or lymphoma). In addition, the ideal candidate would have: A solid background in all phases of clinical development which includes: o Development of clinical development strategy incorporating innovative endpoints, biomarkers, structured decision-making and analysis of the competitive landscape o Clear track record of successful execution of clinical trials from Phase I through Phase III; (Phase IV a plus) o Clinical elements of IMPD or IND submission o Maintenance of clinical program budgets and timeline o Interpretation, summarization and presentation of scientific data in industry, academic and regulatory settings o Assistance in the preparation of study reports, investigator brochures and scientific publications o Sound basis of medical knowledge, clinical experience, statistics and pharmaco-economics.
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