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Assoc Dir, Clinical Operations

Full Time | Boston | Massachusetts | United States

About the Job

The Associate Director of Clinical Operations is responsible for leading a team of individuals and for providing comprehensive strategic and operational support for FMI’s participation in clinical trials sponsored by biopharma partners, academic partners, and FMI sponsored research. This role provides leadership and direction to the Clinical Program Leads (CPLs/Sr. CPLs/Principal CPLs), contributes to the development and implementation of the Clinical Operations strategy, represents Clinical Operations and Data Management on cross-functional internal and external governance committees, and ensures consistent implementation and evolution of processes and procedures in support of clinical trials.



Key Responsibilities

• Team Management - Provide leadership and direction to Clinical Program Leads (CPLs, Sr. CPLs, Principal CPLs):

·   Recruit, manage, train and develop staff.

·   Motivate and manage team members through setting of individual goals, providing on-going feedback, and performance evaluations.

·   Delegate and provide general oversight of collaborations by providing program management level guidance to direct reports.

·   Provide matrix support for staff in Clinical Operations on design initiatives to enable critical thinking, planning, prioritization, adherence to study needs and escalation as needed.

·   Facilitate team meetings by creating agendas, identifying priorities/working groups and distributing communications/minutes.

·   Oversee staff expenditures.

·   Manage resources according to department strategy.

·   Review staff deliverables.

·   Maintain knowledge of HR Corporate policies and procedures.

• Program Management, Cross-Functional Leadership & Collaboration:

·   Strategically represent Clinical Operations on cross-FMI initiatives and governance committees (LCT).

·   Recognize and scope value-generating opportunities in the context of new and existing collaborations by bringing together a team of internal stakeholders as a trial/product design and plans are being built out (e.g, Product Development, Life Cycle Teams, Cancer Genomics, Regulatory, Pathology, Clinical Development, Compliance and Lab Operations).

·   Contribute as a thought-partner for innovative study design and execution plans.

·   Oversee FMI-Sponsored research including protocol and consent development, IRB submissions and interactions with Regulatory Authorities.

·   Initiate contracting discussion with legal and external collaborator and maintain a comprehensive knowledge of each executed agreement to ensure progress against deliverables.

·   Meet with internal stakeholders on alignment and towards achievement of project goals, adequate resource availability for delivery on commitments.

·   Assist in preparation for internal and external leadership presentations when requested.

• External Relationship Management:

·   Establish strong partnership/relationship with internal and external stakeholders.

·   Ensure proactive and effective communication internally and externally.

·   Leverage understanding of Partner’s/Collaborator’s structure, people, strategy and communication style and processes to inform decisions.

·   Support and participate in governance committees (JPT/JSC) and working groups as needed.

·   Support partnership negotiations as opportunities for improvements arise.

• Ensure consistent execution of Clinical Operations strategy, processes and procedures:

·   Contribute to design and development of Clinical Operations strategy.

·   Oversee execution of department strategy.

·   Monitor execution of processes to determine points of failure.

·   Identify and mitigate against study risks, partnering with the appropriate internal stakeholders to document any deviations, and analyze/build solutions as appropriate.

·   Support regulatory authority and Sponsor audits and inspections.

·   Escalate compliance issues/risks to Clinical Operations, Medical and biopharma leadership.

·   Create and execute monthly, quarterly and annual financial, capacity and resource planning with department leadership team in close collaboration with Finance and HR Business Partners.

·   Collaborate with internal Technology team in prioritization for development, testing and roll-out of new and updated systems and delegation of appropriate tasks to Principal and/or Senior CPL.

• Contribute to the development and execution of Clinical Operations goals and initiatives:

·   Sponsor departmental or cross-functional projects and initiatives.

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

• Maintain knowledge of current GCP and CGP regulations and guidelines and company policies, SOPs and procedures.

• Other duties as assigned.



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:

• 8+ year of clinical operations experience in a professional life sciences environment

• 5+ years of direct people management or leading a team


Preferred Qualifications

• Masters or Advanced Degree in a business or scientific discipline

• 8-10 years of Clinical Operations experience in the biopharmaceutical or diagnostic industry, or in an academic 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

• Experience:

·   Leading a global team and with leading teams managing innovative clinical research

·   Influencing and negotiating effective solutions within FMI, with FMI’s partners and/or the wider industry through leading change and driving for results

·   Analyzing and applying strategic-thinking, and problem-solving skills with a proven ability to understand business impact

·   Effectively communicating and leading both with and without authority

·   Successfully managing multiple concurrent initiatives and maintaining one’s own workflow in a fast-paced, dynamic environment

·   Utilizing Microsoft Office Suite

• Demonstrated evidence of success working in a cross-functional environment with ability to build strong relationships

• Highly effective teamwork and collaboration skills

• History of leadership and track record of applying strategic and system thinking

• Demonstrated ability to effectively organize and execute tasks

• Demonstrated ability to work well under pressure while maintaining a professional demeanor

• Desire and demonstrated ability to perform both at a strategic leadership level as well as in a hands-on capacity

• Understanding of HIPAA and importance of patient safety and data privacy regulations and guidelines

• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

Apply Now

Internal applicants, please use your FMI email address.

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