OverviewJob Summary
The Senior Director - Executive Medical Director, Drug Development is responsible for implementing clinical drug efforts for Incyte's oncology products (Phase I though Phase III).
Essential Functions of the Job
- Provides guidance for successful implementation and accomplishment of investigator-initiated trials related to product development and life cycle management of a compound.
- Implements the highest ethical and regulatory standards during the investigation and development of anticancer agents.
- Works in partnership with medical affairs for successful launch of future antineoplastic agents.
- Detects and analyzes emergent issues during clinical drug development and develops and implements mitigating strategies.
- Represents Incyte Corporation at key national and international medical and scientific meetings including participation in advisory boards with key opinion leaders.
- Liaises with discovery science to facilitate and further the development of investigational agents from a preclinical stage to clinical development.
- Serves as a source for medical and scientific expertise in oncology for outlining design strategy and execution for anti-cancer drug development.
- 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.
- 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.
- 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).
- 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.
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.
- Board certified or eligible in Oncology preferred.
- Ability to multi-task and work in a dynamic environment.
- Excellent written and verbal communication skills.
Please Note: Candidates with a range of oncology drug development experience are encouraged to apply. The final title and level (Senior Director or Executive Director) will be determined by the hiring team based on relevant experience, scientific expertise, leadership potential, and overall fit for the role.
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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.
