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Senior Clinical Research Executive
2 months ago
Overview
Incyte is a biopharmaceutical organization dedicated to the discovery, development, and commercialization of innovative therapies aimed at addressing significant unmet medical needs in oncology, inflammation, and autoimmunity.
Our commitment lies in the relentless pursuit of excellence in research and development to enhance patient outcomes, positively impact healthcare, and create sustainable value.
We aim to identify and develop first-in-class and best-in-class therapies, advancing a diverse portfolio of both large and small molecules.
Job Summary
This role entails collaborating with physicians within Clinical Development to deliver clinical research support for designated programs based on phase or therapeutic area.
Key Responsibilities
- Development of protocols for clinical trials.
- Contributing to the formulation of program strategies for assigned compounds/programs, including involvement in the preparation of clinical development plans.
- Drafting and reviewing clinical scientific documents such as IND submissions, IND amendments, Investigator Brochures, Annual Reports, and other regulatory submissions.
- Providing clinical insights into electronic Case Report Form (eCRF) design, Statistical Analysis Plan (SAP), and Tables, Listings, and Figures (TLFs).
- Collaborating with study team members to conduct comprehensive and timely reviews of study data, utilizing best practices and available tools to identify and assess data trends.
- Representing clinical development on project teams.
- Establishing relationships with relevant consultants and external experts to gather feedback on protocol design.
- Serving as the clinical lead for study abstracts, posters, oral presentations, and manuscripts related to assigned studies.
- Acting as a liaison to project teams, Contract Research Organizations (CROs), Clinical sub-teams, and other stakeholders.
- Keeping abreast of the competitive landscape concerning assets with similar mechanisms of action and/or evolving standards of care for relevant indications.
Qualifications
- Degree in a scientific or life sciences field; Pharm.D. or Ph.D. preferred.
- A minimum of 8 years of research experience, with at least 5 years in drug development, is required. Alternative drug development experience may be considered.
- Prior experience in Oncology Drug Development is preferred.
- Ability to work independently, manage multiple tasks, and thrive in a fast-paced environment.
- Excellent written and verbal communication skills.
- Strong analytical capabilities.
- Willingness to accommodate up to 20% travel as business needs dictate.
