Job Summary (Primary function)
Essential Functions of the Job (Key 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 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.
Qualifications (Minimal acceptable level of education, work experience, and competency)
·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 OR equivalent experience as an attending physician in an oncology or hematology setting.
·Prior Immuno-oncology experience is preferred.
·Board certified or eligible in oncology preferred.
·Excellent written and oral communication skills.
·Ability to multi-task and work in a face paced environment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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