Associate to Executive Director, Clinical Scientist, Clinical Pharmacology

InCyte•Wilmington, DE

59d

About The Position

Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) This position is responsible for working with the physicians within Clinical Development to provide clinical research support for programs as assigned by phase or therapeutic area. Essential Functions of the Job (Key responsibilities) Development of protocols for clinical studies. Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans Responsible for providing clinical input into eCRF design, SAP, and TLFs. Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends. Represent clinical development on project teams. Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design. Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies. Serve as liaison to project teams, CRO's, Clinical sub-teams, and others. Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.

Requirements

Degree in scientific/life-sciences field.
Pharm.D. or Ph.D. preferred.
Minimum of 8 years of experience in research with at least 5 years of drug development experience are required.
Alternative drug development experience will be considered.
Ability to work independently, multi-task, and work in a dynamic environment.
Excellent written and verbal communication skills.
Strong Analytical ability.
Ability to accommodate up to 20% travel or as business dictates

Nice To Haves

Prior Oncology Drug Development experience is preferred.

Responsibilities

Development of protocols for clinical studies.
Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
Responsible for providing clinical input into eCRF design, SAP, and TLFs.
Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
Represent clinical development on project teams.
Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
Serve as liaison to project teams, CRO's, Clinical sub-teams, and others.
Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.