Strategic Feasibility Expert

Band Level 5 Job Description Summary

Position Location:

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

Oversees all operational aspects of clinical trials end-to-end, including planning, execution, interpretation of clinical trial research, data collection activities, and clinical operations.

Provides complete oversight of budget and resource allocation within the assigned trial, drives operational excellence through process improvement and knowledge sharing across trials within the program or franchise, and enables an empowered organization capable of navigating a matrix environment and adjusting quickly to business needs. Acts as the point of escalation for resolution of trial management operational issues.

The CSE Group Head (CSE GH) supervises Clinical Scientific Experts (CSE I/ CSE II) and is responsible for competency building of the team by coaching the Clinical Scientific Expert. The CSE GH facilitates allocation across Development Programs/Brands for planning and tracking all activities pertaining to one or more Development Programs or Brands. Responsible for allocating/balancing resources in alignment 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, 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 or 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 or sites.
• Maintains knowledge of investigators and sites mapping in alignment with TA/indication strategy.
• Maintains awareness of site performance data such as recruitment, time to contract, and 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 the 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 or 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 the 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 a team member.
• Leads cross‑functional process improvement initiatives and develops best practices for feasibility and site selection activities.

• Bachelor’s degree required;
  Master’s degree or…