Clinical Program Leadership

Clinical Program Leadership merges in-depth clinical and scientific expertise with broad operational knowledge to lead the Clinical Development Teams (CDT, to develop effective and innovative Clinical Development Plans (CDP) and represent Clinical Development as a key Program Team member. This individual takes a broad, strategic leadership role in ensuring the successful clinical development of drug candidate (s). across multiple indications for an individual development compound with a complex CDP, or across multiple compounds in development)

This individual takes a broad, strategic leadership role in ensuring the successful development of drug candidates.

Clinical Development Team (CDT) Leadership

• 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/program 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 physician. 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/Asset Team Member
• In conjunction with Lead MD responsible to report on the status of the CDP and clinical program
• May interface with to key external stakeholders (KOL’s, advocacy groups, partners etc)

Operational Leadership

• 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 an overall program level operations 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
• Minimum of 12 years global matrix drug development clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget.
• Demonstration of project/program manage

Clinical Program Leadership merges in-depth clinical and scientific expertise with broad operational knowledge to lead the Clinical Development Teams (CDT, to develop effective and innovative Clinical Development Plans (CDP) and represent Clinical Development as a key Program Team member.