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Sr. Director to Executive Director, Oncology Drug Development Wilmington United States,  


Posted on : 13 May 2017

Project Description

  This position is responsible for implementing clinical drug efforts for Incyte's oncology products (Phase I though Phase III).  Job Responsibilities  Provides medical and scientific expertise for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical scientists, biostatisticians, pharmacokineticists, pharmacovigilance and clinical operations  Interacts with global regulatory bodies including the FDA and EMA to accomplish tasks related to oncology product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) and New Drug Applications (NDAs)  Facilitates the development of key internal and external documents pertaining to product development including clinical study protocol, informed consents, CRFs, CSRs, meeting abstracts, scientific journal publications, strategy documents and project plans  Collaborates with external vendors such as CROs, external imaging and laboratory resources, as well as global pharmaceutical companies for successful implementation and conduct of early phase and registration global clinical studies  Serves as a source for medical and scientific expertise in oncology for outlining design strategy and execution for anti-cancer drug development  Liaises with discovery science to facilitate and further the development of investigational agents from a preclinical stage to clinical development  Represents Incyte Corporation at key national and international medical and scientific meetings including participation in advisory boards with key opinion leaders  Detects and analyzes emergent issues during clinical drug development and develops and implements mitigating strategies  Works in partnership with medical affairs for successful launch of future anti­neoplastic agents  Implements the highest ethical and regulatory standards during the investigation and development of anticancer agents  Provides guidance for successful implementation and accomplishment of investigator initiated trials related to product development and life cycle management of a compound  Minimum Requirements  M.D. or D.O. degree with a minimum of 3 - 5 years of experience in oncology drug development in a biotechnology or pharmaceutical company. Immune-oncology experience is strongly preferred.  Board certified or eligible in Oncology preferred Experience with biologics is a plus Excellent written and oral communication skills   Ability to multi-task and work in a face paced environment 

Locations

Wilmington DE

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