About the Job

The Sr. Director Strategic Operations and Clinical Trial Solutions in Clinical and Scientific Operations (CSO) is responsible for the development and implementation of a comprehensive strategy governing the internal processes, systems, training, and tools that support the regulated activities of the Clinical Operations, Data Management, Regulatory Affairs, and Diagnostic Development teams. This role leads the operational strategy to develop, implement and maintain clinical trial solutions to support and enhance FMI’s profiling and monitoring business for Clinical Trials, focusing on external facing tools for BioPharma Partners such as TrialBoostTM, Patient Identification and Planner. This role also manages the internal project leads and project managers who support both internal and cross-functional OKRs and projects to improve our operations, and drives a holistic communication strategy with effective change management tools and methodologies. As a member of the senior leadership team, this role contributes to the overall development and delivery of the department strategy and vision, provides insights to operations for decision making and acts as a hub for process, product and training innovation within the department.

Key Responsibilities

Develop and Drive Strategic Initiatives, Process Development and Training strategy

• Develop and drive an innovative process and training strategy in support of efficient, effective and regulated delivery of clinical trials, CDx and Assay validation activities.
• Act as an innovation hub within Clinical and Scientific Operations to design and implement new concepts as they relate to our processes, systems and training
• Partner with cross-functional colleagues to continuously drive improvement and innovation across internal processes and systems.
• Manage department learning space with identification of learning needs linked to current Clinical and Scientific Operations strategy and maintenance of associated learning resources.
• Establish Key Performance Indicators/Key Quality Indicators and implement required dashboards/reports to monitor the effectiveness of processes and trigger process improvement if required.
• Sponsor internal initiatives to improve core processes and tools.

Develop and drive the Strategy to launch new product solutions and maintain and enhance the clinical trial solution portfolio to support FMIs Profiling and monitoring studies

• Develop and drive the Patient Matching and Clinical Trial Solutions strategy for an area of the business that has a major corporate impact to BioPharma revenue.
• Responsible for the identification of high priority solutions based on insights (market and industry) and analytics as it relates to Oncology Clinical Trials and NGS in order to differentiate FMI’s offerings to support Profiling Studies and FMI priorities
• Supervise cross-functional buy/build/partner analysis with appropriate internal stakeholders and endorse offerings with BioPharma, Commercial, and ClinOps/Data Management Leadership Teams
• Partner with BioPharma and Product Marketing to define the value and set pricing for the offering, develop external collateral and marketing material to use in BioPharma sales pitches and on FMI website, and develop internal sales support collateral
• Collaborate with BioPharma and Commercial LT to influence growth and adoption of FMI’s products and expansion of portfolio of FMI’s clinical trial solutions
• Define and monitor Key Performance Indicators as implemented by the team to measure the success of offerings, including market penetration, as well as optimization of the process or system solution to enhance the offering
• Review periodic executive reports/dashboards on offerings to highlight customer success and challenges, and communication of offering improvements

Provides Leadership and Direction to the Strategic Operations and Clinical Trial Solutions team.

• This role leads a team of Project Managers, Program Managers, Process & Training, and Clinical Product Managers providing comprehensive strategic and operational management of FMI’s clinical trial solutions/products and internal process and training landscape.
• Motivates and manages team members so that employees are developed, contribution is maximized, and performance is actively managed. Ensure all employees have clear roles and responsibilities and that communication and employee relations are managed.

Deliver Tools and Resources necessary to maintain Department Infrastructure and Operations.

• Improve department infrastructure and operations through provision of staff and tools focused on project management, communication and change management.
• Develop and deliver a resourcing and capacity model.
• Create and execute monthly, quarterly and annual financial, capacity and resource planning with input from leadership in close collaboration with Finance and HR Business Partners.
• Provide planning and coordination for goals/initiatives from development to deployment of deliverables.
• Drive analytics and reporting for monitoring of effectiveness and compliance of process landscape and create a flexible metrics platform for quicker reporting.
• Design an agile communications strategy to include the use of visualization tools, multimedia, and social media channels.
• Cultivate influential and effective partnerships with stakeholders in BioPharma, Technology, Commercial, Compliance, Corporate Development & Strategy, and peer partners within Clinical Operations and Data Management

Drive Cross-Functional Collaboration and Strategies

• Strategically represent Clinical and Scientific Operations on cross-FMI initiatives and governance committees
• Recognize and scope value-generating opportunities in the context of new and existing collaborations by bringing together a team of internal stakeholders as a product design and plans are being built out.
• Contribute as a thought partner for innovative study design and execution plans
• Select and prioritize strategic projects and initiatives in collaboration with management
• Lead major strategic projects or initiatives as prioritized
• Maintain knowledge of current GCP, CGP and device regulations and guidelines and company policies, SOPs and procedures.
• Other duties pertinent to strategic operations as occasionally assigned.

Qualifications

Basic Qualifications

• Bachelor’s degree or equivalent in scientific field or equivalent combination of education, training and experience

• 12+ years of 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

• 10+ years of Operations experience in the biopharmaceutical or diagnostic industry with a focus on clinical trials and/or CDx development

• Expert knowledge of drug and device development process and international regulations and guidelines as they apply to the conduct of clinical trials with companion diagnostic development

• Experience:
  • Influencing and negotiating effective solutions, with BioPharma 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

• 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

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

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