Senior Director - Executive Director, Hematology Oncology Drug Development
On-siteWilmington, Delaware, United States
Job Summary
Implement clinical drug efforts for Incyte's oncology products from Phase I through Phase III, providing guidance for investigator-initiated trials and life cycle management. Detect and analyze emergent issues during development to develop and implement mitigating strategies while liaising with discovery science to advance investigational agents from preclinical to clinical stages. Represent Incyte at key national and international medical and scientific meetings, including advisory boards with key opinion leaders. Collaborate with external vendors such as CROs and global pharmaceutical companies to conduct early phase and registration global clinical studies. Facilitate the development of key internal and external documents including clinical study protocols, informed consents, CRFs, CSRs, meeting abstracts, scientific journal publications, strategy documents, and project plans. Interact with global regulatory bodies including the FDA and EMA to oversee clinical research plans for Investigational new Drug applications and New Drug Applications. Provide medical and scientific expertise for internal cross-functional team members including discovery scientists, medical scientists, biostatisticians, pharmacokineticists, pharmacovigilance, and clinical operations.
Required Qualifications
- M.D. or D.O. degree
- 3-5 years of experience in oncology drug development in a biotechnology or pharmaceutical company
Desired Qualifications
- Board certified or eligible in Oncology preferred
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