Principal Clinical Program Lead

Foundation Medicine•Boston, MA

4d•$125,000 - $160,000•Onsite

About The Position

The Principal Clinical Program Lead in Clinical Operations and Data Management provides strategic and operational support for FMI’s participation in clinical trials sponsored by biopharma partners, academic partners, and FMI. The role independently manages a portfolio of studies, with a focus on leading and delivering FMI-sponsored research. It develops, implements, and monitors execution plans from study intake through final deliverables, contributes to the design of FMI-sponsored research, and supports day-to-day project management, operational excellence, and clinical trial oversight. The position works with internal and external stakeholders to manage deliverables, timelines, resources, and critical-path activities, and represents Clinical Operations on FMI governance committees, including the LCT Clinical Subteam. The role leads study design and start-up, including feasibility assessment, approval processes, protocol and consent development, contracting, IRB submissions, study materials, and training. It manages trial implementation and execution, budgets, milestones, sample forecasting, resource planning, data and report delivery, risk management, compliance, and study close-out. It also leads process improvement initiatives, supports audits, addresses process deviations and CAPAs, and maintains partner and stakeholder communications.

Requirements

Bachelor’s degree in a scientific field or at least 4 years of clinical trial or data management experience in lieu of a degree.
At least 6 years of clinical operations experience in a professional life science environment.

Nice To Haves

Master’s or advanced degree in a business or scientific discipline.
At least 8 years of clinical operations experience in the biopharmaceutical or diagnostic industry, or at an academic medical center.
At least 5 years of professional or academic experience in clinical oncology trials.
At least 5 years of professional or academic experience in a Clinical Research Organization or laboratory vendor environment.
At least 5 years of professional or academic experience handling complex clinical data sets, including genomic data.
Proficiency with Microsoft Office Suite.
Demonstrated ability to lead innovative clinical research.
Expert knowledge of the drug development process and ICH GCP regulations and guidelines as they apply to global clinical trials.
Ability to influence and negotiate effective solutions within FMI, with partners, and across the industry by leading change and driving results.
Demonstrated ability to organize and execute tasks effectively.
Demonstrated success managing multiple concurrent initiatives and maintaining an effective workflow in a fast-paced, dynamic environment.
Excellent analytical, strategic-thinking, and problem-solving skills, with the ability to understand business impact.
Evidence of success working cross-functionally and building strong cross-functional relationships.
Excellent attention to detail.
Understanding of HIPAA, patient safety, and data privacy guidelines and regulations.
Ability to work under pressure while maintaining a professional demeanor.
Commitment to reflect FMI’s values of Integrity, Courage, and Passion.

Responsibilities

Lead the design of FMI-sponsored research and manage FMI platform trials.
Lead and manage complex clinical trial design and companion diagnostic studies supporting biopharma and academic trials.
Manage a partner-focused portfolio of trials, potentially with Clinical Program Leads or Senior Clinical Program Leads supporting individual studies.
Lead or sponsor internal initiatives to improve Clinical Operations processes and tools.
Represent Clinical Operations in cross-FMI initiatives and governance committees, including the LCT Clinical Subteam.
Lead study intake, assess feasibility with internal stakeholders, obtain FMI approval, finalize statements of work, and communicate decisions to external partners.
Lead protocol and consent development as appropriate to collaboration scope.
Lead FMI study start-up activities, including contracting, IRB submission and approval, preparation of study materials, project plans, and sample-processing guidelines.
Collaborate with partners to establish working approaches and optimize communication and sharing of tools.
Develop and deliver study start-up training for partners, external clinical trial sites, and internal stakeholders as required.
Manage implementation, timely execution, and conduct of FMI-supported clinical studies, including milestones, timelines, deliverables, budgets, finances, sample forecasting, invoicing, and resources.
Oversee cross-functional study team members to ensure clinical programs are initiated and executed within approved budgets and timelines.
Ensure effective delivery of study data and reports.
Collaborate with Clinical Program Leads, laboratory teams, and Process Specialists to maintain sample tracking and chain of custody from accessioning through data and report delivery.
Partner with Data Management and Data Reporting teams to deliver quality data products on time and in line with partner expectations and contractual commitments.
Identify and mitigate study risks, escalating issues as needed.
Resolve issues involving sample receipt, accessioning, tracking, genomic analysis, report generation, and dissemination.
Track and communicate program and study progress to partners using detailed dashboards and trackers.
Provide portfolio updates and escalate issues to FMI leadership, including Clinical Operations and Data Management, Alliance Management, and Clinical Development.
Document and communicate decisions and updates about timelines and deliverables in a timely manner.
Support sample return and destruction processes for partner and collaborator samples.
Support partner, collaborator, and internal process audits.
Contribute to study close-out reports and close studies in FMI systems.
Lead Clinical Operations initiatives to improve clinical operations and data management processes.
Serve as an FMI resource on clinical trial regulations.
Track, resolve, and communicate nonconformance reports and process deviations that directly affect clinical trials.
Initiate corrective and preventive actions with Process and Training Leads and Quality Assurance.
Maintain documentation of key internal and external study contacts.
Build and maintain internal and external stakeholder relationships and provide study updates to Clinical Operations and biopharma leadership.
Lead partner-facing study meetings.
Monitor the competitive landscape and changing regulations and guidance, assess their impact on clinical projects, and make modifications as necessary.
Approach challenges and problem resolution creatively to optimize clinical trial conduct.
Perform other duties as occasionally assigned and comply with FMI attendance policies.