Strategic Feasibility Expert

Position Location

Cambridge, MA (Hybrid). Please only apply if this location is accessible for you.

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.
• Drive operational excellence through process improvement and knowledge sharing across trials within program/franchise.
• Enable an empowered organization that can navigate in a matrix environment and adjust quickly to business needs.
• Act as point of escalation for resolution of trial management operational issues within assigned trial.
• Applicable to Clinical Scientific Expert Group Head:
  The CSE Group Head supervises Clinical scientific experts (CSE I / CSE II). Responsible for competency building of the team by coaching the Clinical Scientific Expert.
• Facilitate allocation across Development Programs/Brands for planning and tracking all activities pertaining to one or more Development Programs/ Brands.
• Allocate/ balance 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.

• Provide 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.
• Be accountable within the CTT for appropriate site identification and anticipating and relaying hurdles/delays for consideration in ultimate selection and timelines.
• Consolidate feasibility feedback and potential site list for CTT decision making.
• Act as point of escalation when a site selection or sourcing challenge is identified which can impact the trial timelines.
• Engage internally and externally to identify new investigators/sites.
• Maintain knowledge of investigators/sites mapping in alignment with TA/indication strategy.
• Maintain awareness of site performance data (e.g., recruitment, time to contract, master agreements (MSAs)).
• Identify and maintain relationships with key strategic investigators, sites, and networks for a given indication, program, or TA.
• Identify and establish strategic partnerships as appropriate.
• Initiate and ensure confidentiality disclosure agreements (CDAs) and consultancy agreements (CSAs) for assigned TA, according to ethics and compliance standards and to team timelines.
• Work closely with the CTT during protocol development to understand site specifications and to provide robust input into the study operational plan.
• Work closely with the Clinical Finance Manager (CFM) to provide input to site budget, timelines, and TTG impact.
• Request Grant Plan.
• Conduct/advise patient recruitment strategy, enrollment projections, and scenario modeling to improve reliability of forecasting at trial, country, and/or site level.
• Maintain awareness of country related impacts on recruitment and budget to guide clinical trial global footprint and optimize most effective recruitment.
• Work in close collaboration with the Global Development Operations-Trial Monitoring Organization (GDO-TMO) to ensure a timely handover of the strategic feasibility information package for the site‑specific operational feasibility.
• Organize regular TA portfolio reviews for early planning and communication.
• Liaise with other line functions (e.g., Early Regulatory Affairs, Patient Engagement & Advocacy) for alignment and input into feasibility considerations.
• Participate 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 8–10 years of experience in the pharmaceutical, biotechnology, or CRO drug development environment.
• Strong…