Role Summary
Lead clinical trial strategy for assigned program(s) within the clinical development team, coordinating with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. The clinical development team advances a compound through its life cycle management. Location: Cambridge, MA; Morristown, NJ. Responsibilities
Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies. Leads, supports and oversees the execution of clinical development and studies activities, including but not limited to:
Authors abbreviated protocol. Reviews the final protocol and protocol amendments. Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form. Reviews the study specific committee charters. Leads study specific committees with operational support. Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries. Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine.
Participates and contributes to regulatory and safety documents and discussions
Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP Participates in Advisory Committee preparation
Scientific data evaluation and authorship
Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate Supports the planning of advisory board meetings. Presents and discusses development strategy and clinical study results with external investigators and advisory boards, as appropriate
Qualifications
MD degree or equivalent, with Medical Oncology fellowship. Hematology/Oncology fellowship or experience (4+ years) in Oncology Development Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years) Experience in clinical development, late-stage preferred Demonstrated ability to interact productively with external investigators Demonstrated ability to work with a multifunctional team to achieve project milestones Understanding of and willingness to meet applicable regulatory, quality and compliance standards
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Lead clinical trial strategy for assigned program(s) within the clinical development team, coordinating with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. The clinical development team advances a compound through its life cycle management. Location: Cambridge, MA; Morristown, NJ. Responsibilities
Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies. Leads, supports and oversees the execution of clinical development and studies activities, including but not limited to:
Authors abbreviated protocol. Reviews the final protocol and protocol amendments. Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form. Reviews the study specific committee charters. Leads study specific committees with operational support. Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries. Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine.
Participates and contributes to regulatory and safety documents and discussions
Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP Participates in Advisory Committee preparation
Scientific data evaluation and authorship
Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate Supports the planning of advisory board meetings. Presents and discusses development strategy and clinical study results with external investigators and advisory boards, as appropriate
Qualifications
MD degree or equivalent, with Medical Oncology fellowship. Hematology/Oncology fellowship or experience (4+ years) in Oncology Development Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years) Experience in clinical development, late-stage preferred Demonstrated ability to interact productively with external investigators Demonstrated ability to work with a multifunctional team to achieve project milestones Understanding of and willingness to meet applicable regulatory, quality and compliance standards
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