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.
Job Summary (Primary function)
Under the guidance of the Associate Director, Study Start-Up, this position will be responsible for conducting end-to-end site start-up from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and all study/site start-up, maintenance and close-out activities.
Essential Functions of the Job (Key responsibilities)
Assist in development of in-house model process documents.
Serve as an SSU Lead, a primary point of contact to study team on end-to-end study activity.
Lead SSU study team meetings as appropriate.
Utilize Study Start Up tools to track activities and develop reports.
Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
Oversee site contract/budget negotiations (Confidentiality Agreement and Clinical Trial Agreements).
Oversee essential document collection, tracking & review.
Support the collection of country and site level intelligence.
Support Ethics Committee and Regulatory Authority submissions.
Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a study as appropriate.
Manage processes and the execution of Pre-Study evaluations for in-house model studies as well as for outsourced studies.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's Degree in Business Administration, Finance, science or related field.
Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
Flexibility to assume a workload, which frequently necessitates an adjustment of priorities.
Goal oriented, self-starter with proven ability to work independently.
Able to proactively identify issues and provide potential solutions for resolution.
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
Proficiency with Veeva Vault and all applications of Microsoft Office.
Good interpersonal skills.
Comfort with ambiguity; ability to act without having the total picture.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.