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.
• Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
• Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
• 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.
Qualifications (Minimal acceptable level of education, work experience, and competency)
• 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.
• Prior Oncology Drug Development experience is preferred.
• Ability to work independently, 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
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.
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