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Job Title: Clinical Operations Lead
Job Duration: 8 Months
Job Location: Cambridge, MA
• Proven ability to lead effectively in a matrix environment
• Management or Sr. Level experience in biotech or pharma industry with strong preference for candidates with at least 2-3 years of experience in a similar role who have the ability to operate with a high level of independence and minimal oversight
• Demonstrated drug development expertise that includes participation in or leading CDP strategic planning and timing
• Strong track record of clinical operations experience (planning, oversight of programs and studies as well as vendor delivery), in a management level role
• Superior communication skills, high level of professionalism in this highly visible role with proven ability communicate credibly to stakeholders of all levels across multiple disciplines.
• Successful candidates will be self-starters and highly motivated with the ability to adapt to changing priorities in a fast-paced environment
• Actively leads a highly performing CDT. Ensures appropriate strategic topics are discussed and managed
• Collaborates with Core CDT members to ensure that the program has an Clinical Development Plan (CDP) that meets the strategic objective of the asset plan and has been updated and approved by appropriate approval/governance bodies at appropriate time points
• Leads through influence and effectively communicates/collaborates in a highly matrixed organization
• Is responsible for the development and execution of the clinical development plan (CDP) In conjunction with the Lead MD for the program. Contributes to the development of CDP and IDP/asset plan from both a strategic (eg key decision points and risk, study scenario planning) and operational perspectives (eg study timelines and financials)
• Represents CDT and GCO as a key Program Team Member
• In conjunction with Lead MD responsible to report on the status of the CDP and
• May interface with to key external stakeholders representing the program and client (KOL's, advocacy groups, partners etc)
• Provides high level oversight of the individual studies in the CDP (matrix leadership of the Clinical Operations Leads (COL)/ Study Management Team (SMT ) and ongoing review to ensure adherence with key parameters (eg, time, cost, quality) of the CDP
• Accountable for operational delivery of all studies within the CDP through the program lifecycle (from planning, execution, data delivery and inspection planning and support activities)
• Leverages deep operational expertise to develop comprehensive program level strategy that complements the indication, science and strategic intent of the CDP
• Collaborates with key stakeholders internally and externally to understand the global therapeutic landscape. Leverages this knowledge for the benefit of the program (eg establishing geographic recruitment strategies)
• Contribute to ongoing process improvement and department initiatives within CPL and GCO
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