Principal Clinical Program Lead

About the Job:

The Principal Clinical Program Lead in Clinical Operations and Data Management provides comprehensive strategic and operational support for FMI’s participation in clinical trials sponsored by biopharma partners, academic partners, and FMI-led trials. This position strategically manages a portfolio of studies independently and efficiently, with a focus on leading and delivering FMI sponsored research. They are not only responsible for developing, implementing and monitoring the execution plans for the clinical studies they support from initial study intake through final project deliverables, but are also responsible for contributing to the design of FMI sponsored research. Principal Clinical Program Lead completes activities including proactive, clear and customer-centric communication, day-to-day project management, operational excellence initiatives, and oversight of clinical trials. The Principal Clinical Program Lead works collaboratively with internal and external stakeholders across functions to manage deliverables, timelines, resource plans and critical path activities, directly impacting the successful implementation and on-going execution of clinical studies. This role strategically represents Clinical Operations on FMI Governance Committees (LCT Clinical Subteam).

Key Responsibilities:

- Overarching Duties:

- Lead design of FMI sponsored research and manage FMI platform trials.

- Lead and manage complex clinical trial design and CDx studies in support of biopharma and/or academic clinical trials.

- Manage a partner focused portfolio of trials; may have Clinical Program Leads (CPLs)/Sr. Clinical Program Leads (CPLs) support execution of individual trials in a portfolio.

- Lead and/or sponsor internal initiatives to improve Clinical Operations processes and tools.

- Strategically represent Clinical Operations in cross-FMI initiatives and governance committees (LCT Clinical Subteam).

- Study Planning and Start-Up:

- Lead study intake process with partner/collaborator, evaluate feasibility of study with internal stakeholders and obtain FMI approval to support clinical trial (via CSP, SRC, or PRORECO meeting) with finalized SOW, and communicate decisions to external partners/collaborators.

- Lead protocol and consent development as determined by scope of collaborations.

- Lead internal FMI study start-up activities including contracting, IRB submission and approval, finalization of study materials including manuals, study specific requisition forms/kits, project specific plans and sample processing guidelines.

- Collaborate with partner to establish working approach, including optimization of communication and sharing of tools.

- Develop and deliver study start-up training with partner and external clinical trial sites as required.

- Develop and deliver study start-up training with internal stakeholders.

- Trial Operations:

- Manage the implementation, on-time execution and conduct of FMI support of clinical studies; including the management of milestones, timelines and deliverables, development and management of budget/finances, sample forecasting and invoicing, and management of resources.

- Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines.

- Understanding of how to support and deliver the trial endgame, which is the data and reports.

- Work and collaborate closely with CPLs/Sr. CPLs, laboratory teams and Process Specialists to ensure sample tracking and chain of custody is maintained from accessioning through data/report delivery.

- Partner with Data Management and Data Reporting team to ensure timely delivery of a quality data product in line with Partner expectations and contractual deliverables.

- Identify and mitigate against study risks, escalating as necessary.

- Engage in problem solving as needed related to sample receipt, accessioning, tracking, genomic analysis, report generation and dissemination.

- Effectively tracks and communicate program/study progress to Partners with ability to create and update detailed dashboards and trackers.

- Provide study updates across partner portfolio and escalate as needed to FMI leadership including Clinical Operations and Data Management, Alliance Management and Clinical Development.

- Ensure timely documentation and communication of decisions and updates on timelines and deliverables.

- Support Laboratory Operations and Process Specialists with sample return and destruction process for partner/collaborator samples.

- Support partner/collaborator and internal process audits.

- Contribute to study close-out reports and close studies within FMI systems.

- Process Oversight and Study Compliance:

- Lead Clinical Operations initiatives to improve clinical operations and data management processes.

- Serve as an FMI resource regarding clinical trial regulations.

- Track, resolve and communicate NCRs/process deviations with direct impact to clinical trials to partners.

- Initiate CAPAs in conjunction with Process and Training Leads and QA to correct and prevent issues from reoccurring.

- Communication/Other:

- Maintain documentation on key study contacts (internal and external)

- Build and maintain relationships with internal and external stakeholders and provide study updates as needed to Clinical Operations and biopharma leadership.

- Lead partner-facing study meetings.

- Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary.

- Creatively approach challenges and problem resolution to optimize the conduct of clinical trials.

- Other duties as occasionally assigned.

- Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

- Bachelor’s Degree in a scientific field or 4+ years of experience in clinical trial or data management roles in lieu of a Degree, AND

- 6+ years of clinical operations experience in a professional life science environment

Preferred Qualifications:

- Masters or Advanced Degree in a business or scientific discipline

- 8+ years of clinical operations experience in the biopharmaceutical or diagnostic industry, or an academic medical center

- 5+ years of professional or academic experience:

in clinical oncology trials

- in a Clinical Research Organization (CRO) or lab vendor environment

- handling complex clinical data sets including genomic data

- Microsoft Office Suite proficiency

- Demonstrated ability to lead innovative clinical research

- Expert knowledge of drug development process and ICH GCP regulations and guidelines as they apply to the conduct of clinical trials globally

- Proven ability to influence and negotiate effective solutions within FMI, with our partners and the wider industry through leading change and driving for results

- Demonstrated ability to effectively organize and execute tasks

- Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow in a fast-paced, dynamic environment

- Demonstrated excellent analytical, strategic-thinking, and problem-solving skills with a proven ability to understand business impact

- Demonstrated evidence of success working in a cross-functional environment; demonstrated ability to build strong relationships cross-functionally

- Excellent attention to detail

- Understanding of HIPAA, the importance of patient safety, data privacy guidelines and regulations

- Ability to work well under pressure while maintaining a professional demeanor

- Understanding of HIPAA and the importance of patient data privacy

- Commitment to reflect FMI’s values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $125,000 - $160,000 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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