at Incyte Corporation in Wilmington, Delaware, United States
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.
The Dir, Clinical Research Scientist is responsible for working with the physicians within Clinical to provide clinical research support for the assigned studies with focus on Immuno-Oncology.
Duties and Responsibilities
Development of protocols for clinical studies.
Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans.
Drafting of clinical scientific documents such as IND, IND amendments, Clinical Study Reports, Investigator Brochures, Annual Reports and other health authorities submissions.
Responsible for providing clinical input into eCRF design, SAP, and TLFs.
Monitor, review and summarize clinical safety and efficacy data in ongoing studies.
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.
Will lead the clinical matrix teams for assigned studies, represent clinical development on project teams and serve as liaison to project teams, CRO's and others.
Provide clinical updates on assigned studies to Sr. management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy and governance meetings, eDMC meetings, steering committees, advocacy groups, scientific advisory boards, and publications committees.
Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed.
Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
Contribute to writing and review of study abstracts, posters, oral presentations and manuscripts for assigned studies.
Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.
Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
Minimum of 4 - 6 years of experience in research with at least 3 or more years of clinical research/drug development experience are required for Director level.
Minimum of 8 years of experience in research with at least 5 years of drug development experience are required for Senior Director level.
Experience in Oncology field is required.
Ability to multi-task and work in a fast-paced environment.
Excellent written and oral communication skills.
Strong Analytical ability.
Ability to accommodate up to 20% travel or as business dictates.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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