SVP, Head of Portfolio Strategy and Operations

Role Overview:

The Head of Portfolio Strategy and Operations (PS&O) drives successful delivery of key corporate objectives by ensuring the robust development of portfolio and program strategy and effective translation of strategy into integrated planning and timely operational execution across Dyne. The Head of PS&O reports into the Chief Executive Officer (CEO) and is a member of the Dyne Executive Committee (EC).

The Head of PS&O oversees Program Leadership, Program Management and Clinical Operations at Dyne by managing, coaching and guiding the Head of Clin Ops, Head of PM and the Program Team Leaders to enable exceptional performance of cross-functional Program Teams and clinical studies across the Dyne portfolio:

• Leads high-performing team of Program Team Leaders, driving the articulation of program strategy, vision, goals and priorities, bringing both a 'future- orientation' toward the ultimate goal of broad, global commercial access for patients in need, and a "pragmatic-orientation" to chart the path, mitigate risks, cultivate options, and lead the company through complex drug development decisions
• Oversees high-performing team of Program Managers, including direct management of the VP, Head of Program Management; driving achievement of company and program goals and the advancement of the company’s portfolio of programs ensuring effective cross-functional contributions from all company functions
• Oversees high-performing Clinical Operations team, including direct management of the VP, Head of Clinical Operations, and overall accountability for team based in US and EU; drives exceptional planning, start-up, conduct and close-out of Dyne clinical studies in line with corporate goals
• Articulates and drives the vision for how to build and scale the PTL, PM and Clin Ops organizations, capabilities, processes and infrastructure to support Dyne future growth

As a member of Dyne Executive Committee, the Head of PS&O partners with Dyne executive leadership team to integrate and harmonize Business Operations across the organization, driving portfolio level cross-program and cross-functional integration, coordination and operations across Dyne:

• Oversees Dyne governance, partnering with executive leadership to ensure timely, high-quality and cross-functional decision-making and information sharing to enable advancement of Dyne portfolio and programs
• Partners on the Dyne strategic planning process with CFO, ensuring development of robust program and project long- and short-range plans in line with corporate goals and resources
• Partners with CMO to build out integrated Development Operations capabilities to enable growth of late-stage development programs and the expansion of Dyne’s clinical pipeline.
• Oversees development of non-program operations to ensure harmonization and alignment of project management discipline and methodology across organization

• Lead and develop team of Program Team Leaders and Program Managers to effectively advance Dyne Programs and foster seamless integration and communication across the company:
  • Drive understanding and inspire the big picture thinking of corporate, portfolio and program strategy and cross-functional interdependencies in order to lead execution across all Programs
  • Partner with Program Team Leaders to provide strategic and operational leadership to programs to achieve Program and company goal

• Ensure effective partnership with cross-functional representatives to develop comprehensive product development, commercialization and lifecycle management plans that optimize: value, time, resources, risk, and alignment with business objectives
• Oversee and enable high-performing cross-functional Program Teams, focusing on both the "what", such as strategy, priorities, output, and resources, and also the "how", such as maintaining a fulfilling, collaborative, and sustainable team environment
• Establish a robust and well-understood Program strategy for bringing a life-changing medicine to patients in need
• Effectively manage the Program Team model at Dyne:
  • Develop and maintain clear Program plans understood by all team members with all key activities, deliverables, responsibilities, and timing
  • Enable clear strategic decision making (articulate and align on timing and approach for key decisions; prepare effective analyses and materials for decisions; ensure decisions are understood and implemented), scenario planning and options analysis
  • Ensure “health” of PT and Sub-Teams by proactively managing members’ engagement, communications, expectations, issue resolution, etc.

• Develop foundations for effective Portfolio Management (integrated portfolio views; key milestones and decisions; portfolio scenarios for effective optimization)
  • Develop, maintain and make available Portfolio views in synch with Program plans and Dyne financials plans
  • Drive Portfolio Review preparation and decisions
  • Partner and Support yearly financial planning and LRP work
• Lead and develop Clinical Operations team to effectively advance Dyne portfolio of clinical studies:
  • Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed to a high degree of quality across all clinical stage programs
  • Develop and implement a clinical vendor oversight process with documentation to record transfer of regulatory responsibilities, evaluation of performance, and escalation of issues
• Establish, implement, and proactively manage clinical trial processes, strategic outsourcing, and performance indicators
• Ensure high standards for compliance and quality within the Clinical Operations team and across clinical trial vendors with company SOPs,  ICH-GCP guidelines that govern regulations, and patient safety standards
• Regularly report clinical trial status, identify challenges and program/resource gaps, and devise and implements solutions
• Provide strategic input to clinical-trial related risk analysis and mitigation strategies
• Oversee the development and review of clinical program budgets, and track and forecast spend for initiated studies
• Lead or oversee the authorship of Clinical Operations SOPs and other function-specific documentation; participate in cross-functional SOP development and infrastructure initiatives

Knowledge & Skills

• Experience in Phase 1-3 drug development is required; product launch/early commercialization experience a strong plus
• Proven and respected leader with:
  • Advanced degree in Medical or Life Science, MD, PhD or MBA or equivalent
  • 15+ years of experience in pharmaceutical industry in leadership positions in drug development and proven track record in driving Programs through IND, early clinical, pivotal stages and approval
  • And/or at least 12 years in pharmaceutical industry in significant development and/or commercial leadership or general management positions including working with development teams in cross-functional setting, with exceptional track record of delivering on business objectives, activity/milestones leading to filing and launching, and strong knowledge of neuromuscular diseases
  • Experience in rare genetic diseases preferred
  • Previous Clinical Operations functional and/or program leadership, including hiring and managing Clinical Operations staff, selecting and managing vendors/CROs, and optimizing resources across clinical studies

• Business-oriented leader, able to shape and communicate the vision for the Dyne portfolio and programs and guide the development of the product strategy and its execution
• Natural focus on team dynamics; insightful people leader supporting and coaching high-caliber functional experts to achieve their absolute best
• Demonstrated experience in building highly effective teams and guiding teams and organizations in making complex and high-stakes data-driven decisions
• Outstanding sense of urgency and ability to pace the team’s work to achieve milestone achievement in highly competitive environment
• Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams
• Comfort with ambiguity and ability to provide steadiness and consistency in environment of shifting priorities, demands and timelines

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