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 (HEM/ONC/I&I) and type of therapy.
Duties and Responsibilities
&bull CRS lead on assigned phase studies in hematology, oncology or I&I
&bull Development of protocols for clinical studies.
&bull Drafting and review of clinical scientific documents such as IND, Investigator Brochures, Annual Reports and
other Health Authority submissions.
&bull Monitor, review and summarize safety and efficacy data in ongoing studies.
&bull Develop relationships with appropriate consultants and external experts
&bull Represent clinical development on project teams.
&bull Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
&bull Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
&bull Serve as liaison to project teams, CRO&rsquos, specific vendors in collaboration with Clin Operations, Clinical sub-teams, and others.
&bull Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.
Requirements
&bull Degree in scientific/life-sciences field. Ph.D. or Pharm.D. preferred.
&bull Minimum of 6 years of experience in clinical development with at least 4 years of clinical research scientist experience are required.
&bull Prior early development experience is strongly preferred
&bull Prior Hematology, Oncology or I&I Clinical Drug Development experience is preferred.
&bull Ability to work independently, multi-task, and work in a fast-paced environment.
&bull Excellent written and oral communication skills.
&bull Strong Analytical ability.
&bull 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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