Director to Executive Director, Immuno-Oncology Development (MD)
This position is responsible for implementing clinical drug efforts for Incyte's oncology products (Phase I though Phase III) for immuno-oncology.
Duties and 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, pharmacovigilence 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, investigator brochure, 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 anti¬neoplastic 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;
Contribute positively to a strong culture of business integrity and ethics;
Act within compliance and legal requirements as well as within company guidelines.
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;
Board certified or eligible in Oncology preferred;
Excellent written and oral communication skills;
Ability to multi-task and work in a face paced environment.