Strategic Feasibility Expert

This role is based in Cambridge, MA. Please only apply if this location is accessible for you.

Position Location:

Cambridge, MA

Oversees all operational aspects of clinical trials end-to-end including the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Complete oversight of budget and resource allocation within assigned trial. Drives operational excellence through process improvement and knowledge sharing across trials within program/franchise. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs.

Point of escalation for resolution of trial management operational issues within assigned trial.

Applicable to Clinical Scientific Expert Group Head:
The CSE Group Head (CSE GH) supervises Clinical scientific experts (CSE I/ CSE II). Responsible for competency building of the team by coaching the Clinical Scientific Expert. The CSE GH facilitates their allocation across Development Programs/ Brands for planning and tracking all activities pertaining to one or more Development Programs/ Brands. Responsible for allocating/ balancing resources aligning with Clinical Development Functional Heads (CD-FH), Global Program Clinical Heads (GPCH), Therapeutic Areas Heads (TA Heads) and based on the Development Unit/portfolio needs.

• Provides early, strategic feasibility input (including early medical and operational feasibility) for a given therapeutic area (TA), indication, or study, through the utilization of relevant tools, databases, and historical metrics.
• Accountable within the CTT for appropriate site identification and anticipating and relaying hurdles/delays for consideration in ultimate selection and timelines. Consolidates feasibility feedback and potential site list for CTT decision making. May act as the point of escalation when a site selection or sourcing challenge is identified which can impact the trial timelines.
• Engages internally and externally to identify new investigators/sites. Maintains knowledge of investigators/sites mapping in alignment with TA/indication strategy. Maintains awareness of site performance data e.g. recruitment, time to contract, master agreements (MSAs).
• Identifies and maintains relationships with key strategic investigators, sites, and networks for a given indication, program, or TA. Identifies and establishes strategic partnerships as appropriate.
• Initiates and ensures confidentiality disclosure agreements (CDAs) and consultancy agreements (CSAs) for assigned TA, according to ethics and compliance standards and to team timelines.
• Works closely with the CTT during protocol development to understand site specifications and to provide robust input into the study operational plan.
• Works closely with the Clinical Finance Manager (CFM) to provide input to site budget, timelines, and TTG impact. Requests Grant Plan.
• Conducts/advises patient recruitment strategy, enrollment projections and scenario modeling in order to improve the reliability of forecasting at trial, country and/or site level. Maintains awareness of country related impacts on recruitment and budget to help guide clinical trial global footprint and optimize most effective recruitment.
• May work in close collaboration with the Global Development Operations-Trial Monitoring Organization (GDO‑TMO), ensuring a timely handover of the strategic feasibility information package for the site‑specific operational feasibility. Organizes regular TA portfolio reviews for early planning and communication.
• Liaises with other line functions, e.g., Early Regulatory Affairs, Patient Engagement & Advocacy, for alignment and input into feasibility considerations.
• Participates in assigned TA Milestone monthly meetings and CTT study planning meetings (from kick‑off to all sites contracted) as team member.
• Lead cross‑functional process improvement initiatives and develop best practices for feasibility and site selection activities.

• Bachelor’s degree required;
  Master’s degree or equivalent preferred
• Degree in Science, Medicine, or Business strongly preferred
• Minimum of…