Opportunity Description
Job Responsibilities
+ Development of protocols for clinical studies.
+ Preparation of clinical development plans.
+ Drafting of clinical scientific documents such as IND, IND amendments, Investigator’s Brochures, Annual Reports and other FDA submissions.
+ Monitor, perform data review, and summarize safety and efficacy data in ongoing studies.
+ Assist with study design for exploratory development.
+ Lead the clinical matrix teams for assigned compounds.
+ Represent exploratory development on project teams.
+ Develop relationships with appropriate consultants.
+ Write abstracts and present data at scientific meetings, both internally and externally.
+ Serve as liaison to project teams, CROs and others
Qualifications
+ Degree in a scientific/life sciences field; Pharm.D. or Ph.D. preferred.
+ Minimum of 8 years of experience in oncology research or related field
+ Development of protocols for clinical studies.
+ Preparation of clinical development plans.
+ Drafting of clinical scientific documents such as IND, IND amendments, Investigator’s Brochures, Annual Reports and other FDA submissions.
+ Monitor, perform data review, and summarize safety and efficacy data in ongoing studies.
+ Assist with study design for exploratory development.
+ Lead the clinical matrix teams for assigned compounds.
+ Represent exploratory development on project teams.
+ Develop relationships with appropriate consultants.
+ Write abstracts and present data at scientific meetings, both internally and externally.
+ Serve as liaison to project teams, CROs and others
Qualifications
+ Degree in a scientific/life sciences field; Pharm.D. or Ph.D. preferred.
+ Minimum of 8 years of experience in oncology research or related field
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