Sr. Clinical Program Lead

Foundation Medicine, Inc. Sr. Clinical Program Lead Location: 400 Summer Street, Boston, Massachusetts, United States Job Type: Full Time About the Job The Sr. Clinical Program Lead in Clinical Operations and Data Management provides comprehensive operational support for Foundation Medicine’s participation in clinical trials sponsored by BioPharma partners, Academic partners, and FMI‑led trials. The position strategically manages a portfolio of studies independently and efficiently. The role develops, implements, and monitors execution plans for the clinical studies from initial study intake through final project deliverables. The lead also contributes to the design of partner and FMI‑sponsored research. Activities include proactive, clear, customer‑centric communication, day‑to‑day project management, operational excellence, and oversight of clinical trials. The Sr. Clinical Program Lead collaborates with internal and external stakeholders across functions to manage samples, timelines, resource plans, and critical‑path activities directly impacting successful implementation and ongoing execution of clinical studies. Key Responsibilities Represent Clinical Operations strategically in governance sub‑committees (Clinical Subteam of LCT). Study Planning and Start‑Up Lead study intake with partners, evaluate feasibility, obtain FMI approval for clinical trials, finalize SOW. Communicate decisions to partners and collaborators. Contribute to study design. Lead internal FMI study start‑up activities: contracting, IRB submission and approval, finalize study materials including manuals, requisition kits, project plans, and sample processing guidelines. Collaborate with partner to establish working approach, optimize communication and sharing. Develop and deliver start‑up training to partner, internal stakeholders, and external clinical trial sites. Trial Operations Manage implementation, on‑time execution, and FMI support of clinical studies, including milestones, timelines, deliverables, budget, sample forecasting, invoicing, and resources. Oversee cross‑functional study team members to ensure timely initiation and execution within approved budget. Support delivery of data and reports (trial endgame). Collaborate closely with Clinical Program Leads, laboratory teams, and Process Specialists to maintain sample tracking and chain of custody from accessioning through data/report delivery. Partner with Data Management and Data Reporting Team to ensure timely delivery of quality data in line with partner expectations and contractual deliverables. Identify and mitigate study risks and raise issues as needed. Engage in problem solving related to sample receipt, accessioning, tracking, genomic analysis, report generation, and dissemination. Track and communicate program/study progress to partners, updating dashboards and trackers. Provide study updates across partner portfolio and communicate escalations to FMI leadership. Document and communicate decisions and updates on timelines and deliverables. Support laboratory operations and Process Specialists with sample return and destruction processes. Support partner/ collaborator and internal process audits. Contribute to study close‑out reports and close studies within FMI systems. Communication / Other Maintain documentation on key study contacts. Build and maintain relationships with internal and external stakeholders and provide study updates to medical and bio‑pharma leadership. Lead partner‑facing study meetings. Stay aware of competitive landscape, regulatory changes, and provide guidance on impact to projects. Approach challenges creatively and resolve problems to optimize clinical trial conduct. Process Oversight and Study Compliance Lead Clinical Operations initiatives to improve processes. Act as FMI resource for clinical trial regulations. Track, resolve, and communicate deviations with partners. Initiate CAPAs with Process and Training Leads, QA to prevent recurrence. Comply with FMI attendance policies. Qualifications Basic Qualifications Bachelor’s Degree or equivalent in a scientific field or combination of education, training, and experience. 4+ years of Clinical Operations experience in a professional life sciences environment. Preferred Qualifications Master’s or advanced degree in a business or scientific discipline. 5+ years of Clinical Operations experience in biopharmaceutical or diagnostic industry, or in an academic center. 2+ years of professional or academic experience in Clinical oncology trials. Clinical Research Organization (CRO) or lab vendor environment. Handling complex clinical data sets including genomic data. In‑depth knowledge of drug development process and ICH GCP regulations and guidelines globally. Proficiency in MS Office Suite. Demonstrated history of successfully managing multiple concurrent initiatives and maintaining workflow in a fast‑paced, dynamic environment. Demonstrated evidence of success working in a cross‑functional environment and building strong relationships. Strong organizational skills. Ability to work well under pressure while maintaining a professional demeanor. Excellent attention to detail. Understanding of HIPAA and importance of patient safety and data privacy regulations. Commitment to reflect FMI’s values: Patients, Passion, Innovation, Collaboration. The expected salary range for this position based on the primary location of Boston, MA is $110,000 – $130,000 per year. A discretionary annual bonus may be available based on individual and company performance. This position also qualifies for Foundation Medicine benefits. #J-18808-Ljbffr Foundation Medicine, Inc.