Medical Director/ Senior MD, Early Clinical Development
Inseriert am: 10.08.2021
Summary
This position is responsible for implementing clinical drug efforts for Incyte's oncology products (Phase I though POC) for 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, EMA and PMDA 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)
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
Requirements
M.D. or D.O. degree with a minimum of 3 - 5 years of experience (6+ years - senior) in oncology drug development in a biotechnology or pharmaceutical company, clinical research experience in academia also acceptable
Board certified or eligible in Oncology preferred
Experience with early phase oncology trials
Excellent written and oral communication skills
Ability to multi-task and work in a face paced environment
