• Conduct in-depth research and analysis to support strategic decision-making across various areas, including market analysis, competitive intelligence, and financial modeling. • Oversee the implementation of the PMO driving strategic initiatives, ensuring alignment across departments and tracking progress against key metrics. • Manage strategic projects from initiation to completion, ensuring on-time delivery and achieving desired outcomes. • Identify and evaluate new business opportunities for expansion and growth. • Monitor industry trends and competitive landscape, providing regular updates to the strategy team. • Identify potential risks and opportunities for the company. • Own the design and evolution of the OKR framework • Drive company-wide OKR cycles (setting, alignment, tracking) • Support and lead/co-lead on monthly / quarterly business reviews (MBRs/QBRs) • Identify performance gaps and drive corrective actions with stakeholders • Establish performance culture (accountability, transparency, data-driven decisions) • Support the preparation of investor materials and participate in investor meetings as needed • Develop and maintain relationships with existing and potential investors and strategic partners. • Support in the development of M&A strategy and framework • Assist in the identification, evaluation, and execution of potential M&A transactions, including due diligence and financial analysis • Ensure to have an always up to date pitch deck and data room for the company • Facilitate communication between the executive team and the board of directors. • Prepare and distribute materials for board meetings, including agendas, reports, and presentations. • Coordinate logistics for board meetings, ensuring that all necessary information is provided to board members in a timely manner. • Assist in the implementation of board decisions and resolutions. • Develop and implement strategies to enhance shareholder value and promote confidence in the organization. • Address shareholder concerns and inquiries, ensuring a positive and transparent communication process

Role Description Foundation Medicine is seeking a strategic and collaborative leader to serve as Senior Director, RA/QA Strategy & Business Integration. This role acts as the primary interface between Regulatory Affairs/Quality Assurance (RA/QA) and cross-functional internal business partners, including Product, R&D, and Operations as well as external business partners. The role is a strategic enabler of innovation, playing a central role in shaping both regulatory and product strategy. The Senior Director ensures quality and regulatory perspectives actively inform development pathways, partnerships, and go-to-market decisions. They will also represent FMI externally, engaging with biopharma partners and at industry forums, while positioning RA/QA as a proactive driver of speed, innovation, and competitive advantage. Key Responsibilities - Strategic Leadership & Business Partnership - Serve as the primary RA/QA leader interfacing with Product, R&D, and Operations, shaping regulatory and product strategy. - Drive early and impactful integration of RA/QA into product development, strategic planning, and decision-making. - Guide development pathways to balance innovation, compliance, speed, and scalability. - Position RA/QA as a strategic enabler of innovation and competitive advantage. - Cross-Functional Leadership & Governance - Lead prioritization of RA/QA engagement based on business impact and strategic importance. - Orchestrate the right expertise across RA/QA (e.g., Software, Device, Laboratory Quality) to support key initiatives. - Ensure consistent, risk-based application of quality and regulatory frameworks across the enterprise. - Act as escalation point for high-impact or ambiguous regulatory and quality decisions. - Operational Excellence & Strategic Enablement - Drive simplification and optimization of RA/QA processes to accelerate development timelines. - Align RA/QA resources to highest-value initiatives, enabling focus on innovation and strategic priorities. - Anticipate emerging regulatory trends, risks, and business needs to inform forward-looking strategy. - External Engagement & Influence - Represent FMI with biopharma partners and in industry forums, shaping external perspectives on regulatory and quality strategy. - Build strong relationships with senior internal and external stakeholders. - Influence key decisions to ensure optimal balance between compliance, innovation, speed, and market impact. - Comply with FMI's attendance policies. Qualifications - Bachelor’s degree in Life Sciences, Engineering, or a related discipline. - 12+ years of experience in Quality Assurance and Regulatory Affairs in biotech, diagnostics, or medical device environments. - Demonstrated experience shaping regulatory strategies and supporting product development in regulated environments (e.g., FDA, CLIA, CAP, IVDR). - Proven track record of influencing cross-functional decision-making across Product, R&D, and Operations. - Experience engaging with external stakeholders (e.g., biopharma partners, regulatory authorities, or industry forums). - 5+ years of leadership experience, including leading through influence in a matrixed organization. Preferred Qualifications - Advanced degree (PhD, MS, MBA, or equivalent). - Deep expertise in regulatory strategy across the product lifecycle, ideally in diagnostics, IVD, or precision medicine. - Experience shaping complex product development programs in close partnership with Product and R&D. - Demonstrated ability to influence senior leaders and drive enterprise-level decisions in a matrixed environment. - Experience representing an organization externally as a thought leader in regulatory and quality strategy. - Track record of building or evolving QA/RA operating models, governance, or strategic capabilities. - Strong understanding of global regulatory environments (e.g., FDA, IVDR) and risk-based decision-making frameworks. Key Competencies - Strategic thinking and enterprise mindset. - Exceptional communication and executive presence. - Cross-functional leadership and collaboration. - Strong judgment and decision-making in complex environments. - Continuous improvement and operational excellence. - Understanding of HIPAA and the importance of patient data privacy. - Commitment to reflect FMI’s values: Integrity, Courage, and Passion. Salary and Benefits The expected salary range for this position based on the primary location of Remote is $230,800 - $288,500 per year. The salary range is commensurate with Foundation Medicine's 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.

• Design and implement frameworks that evaluate provider performance across total cost of care, clinical quality, and downstream utilization • Quantify variation across providers to identify actionable savings opportunities driven by differences in appropriateness, effectiveness, site of service, unit price, and utilization patterns • Develop methodologies to evaluate the downstream impact of provider selection on overall healthcare spend and member outcomes • Translate complex performance and cost dynamics into clear, defensible scoring outputs that are both analytically rigorous and practically actionable • Apply the total cost of care provider scoring framework to develop benefit strategies (e.g., cost-sharing structures, deductible shifts) • Evaluate financial impact of plan changes at the population level and ensure that incentive structures are economically sustainable and aligned to expected savings • Look at what our competitors are doing and identify gaps and opportunity areas (forward looking) • Innovate to anticipate and meet needs of prospective clients/the market • Partner closely with Product, Solution Engineering, Actuarial, and Data teams to inform solution design • Collaborate with market-facing teams on GTM initiatives to refine design to meet the needs of existing clients and to evaluate opportunities for prospective clients • All other duties as assigned

• Synthesize data insights and field feedback from Marketing Managers, Channel Managers, and external partners to create a comprehensive view of Door to Door performance and identify strategic perspectives • Coordinate the assessment of sales initiatives, interpreting performance metrics, ROI, and impact to determine what's driving results and what needs adjustment • Develop and deliver compelling executive presentations and strategic decks that communicate both successes and challenges in a clear, actionable narrative • Collaborate with Marketing Managers and Channel Managers to gather qualitative and quantitative commentary from the field, translating frontline intelligence into strategic recommendations • Support ad hoc requests and interpretation in a fast-paced, evolving landscape, pivoting quickly as business priorities and market conditions shift