Overview:

Summary

This position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase clinical programs as assigned by therapeutic area and type of therapy. Primary focus will be on I&I programs.

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 and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
• Monitor, review and summarize safety and efficacy data in ongoing studies.
• 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, specific vendors in collaboration with Clin Operations, 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 6 years of experience in research with at least 4 years of drug development experience are required. Alternative drug development experience will be considered.
• Prior early development experience is strongly preferred
• Prior I&I 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 travel 20-30% when required.

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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