Clinical Program Leadership

Biogen SANDBOX•Research Triangle Park, NC

About The Position

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 Additional Information 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.

Requirements

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

Responsibilities

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)
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