Senior Director, Program Leader, Corporate Strategy
The Impact You Will Make
Agios Pharmaceuticals is searching for a visionary and strategic Program Leader to serve as the single point of accountability for one of our critical clinical stage programs. This is a rare opportunity to function as the strategic and operational architect of a clinical stage asset, owning its vision and driving its execution from clinical development through regulatory approval, global launch, and lifecycle management.
What You Will Do
Asset Strategy & Vision - Own the fully integrated global asset strategy across the entire product lifecycle — from development candidate through clinical proof of concept, regulatory approval, commercial launch, and lifecycle management — ensuring alignment with Agios’ portfolio and corporate objectives.
Define and continuously evolve the Target Product Profile, Clinical Development Plan, regulatory pathway, market access strategy, and commercial positioning in close partnership with cross-functional leaders and aligned with patient needs.
Identify, assess, and proactively communicate program risks and opportunities to senior leadership and governance bodies, developing clear mitigation strategies and scenario-based contingency plans.
Lead asset presentations at governance meetings to senior leadership, securing endorsement, budget, and resource allocation through rigorous analysis of strategic options, return on investment, and risk.
Drive competitive intelligence and external landscape assessment to anticipate challenges and position the asset for differentiated success globally.
Champion a patient-first mindset in all strategic decisions, ensuring the voice of the patient community is embedded in program direction.
Cross-Functional Leadership & Execution - Lead the Program Team, building a cohesive, high-performing cross-functional team that includes, but is not limited to, Clinical Development, Regulatory Affairs, Commercial, Medical Affairs, Manufacturing/CMC, Market Access, Finance, Legal, and Program Management.
Partner closely with the Program Manager to develop integrated execution plans, timelines, and resource requirements; maintain accountability for delivering against program goals, milestones, and budgets.
Drive timely, well-reasoned decision-making across the organization, using governance structures effectively to resolve complex tradeoffs and keep programs on track.
Ensure that all key program documents — including the Clinical Development Plan, Target Product Profile, regulatory strategy, and commercial readiness plans — reflect full cross-functional input and are kept current.
Lead and mentor sub-team leaders, fostering a culture of accountability, high standards, and continuous improvement across all functions contributing to the program.
Regulatory Strategy & Commercial Alignment - Partner with Regulatory Affairs to guide the global regulatory strategy, including planning and preparation for interactions with the FDA, EMA, and other major health authorities; experience with and understanding of NDA/BLA or equivalent submissions is central to this role.
Ensure alignment of the development plan with commercial objectives, partnering with the Commercial team to anticipate market access challenges and build a globally competitive value proposition.
Collaborate with Medical Affairs and Clinical Development to define and execute the asset’s publication and data dissemination strategy across major scientific congresses and peer-reviewed journals.
Anticipate and navigate evolving regulatory and reimbursement landscapes globally, incorporating external insights into program strategy.
Stakeholder & External Engagement - Serve as a key internal champion and external representative for the asset, partnering with relevant functions to engage key opinion leaders, patient advocacy organizations, potential partners, and the broader scientific community.
Partner with Investor Relations and Corporate Communications to develop and manage external messaging for the analyst community in collaboration with the clinical development lead.
Collaborate with Business Development to evaluate and pursue lifecycle opportunities including partnerships, in-licensing, and co-development alliances that enhance the asset’s value.
Partner across Program Teams to identify synergies, cross-asset learnings, and disease area strategies that benefit the broader Agios portfolio.
Organizational Leadership & Culture - Model Agios’ values and culture — cultivating an environment of collaboration, intellectual courage, and patient focus throughout the Program Team.
Communicate with clarity, candor, and executive presence to all levels of the organization, from Program Team members to senior leadership.
Recruit, coach, and develop team members across the cross-functional Program Team, expanding capability and leadership depth within the organization.
Promote a culture of bold yet disciplined risk-taking and innovation within the program, encouraging diverse perspectives and data-informed decision-making.
What You Bring
Advanced degree (MD, PhD, PharmD, MBA, or equivalent); graduate-level scientific or clinical training strongly preferred given the depth of development expertise required.
10+ years of progressive experience within the pharmaceutical, biotechnology, or biopharma industry, including demonstrated leadership of late-stage or registration-enabling clinical programs.
Demonstrated ability to drive successful product launch and commercialization of innovative, first-in-class therapies, including lifecycle management (LCM) planning and execution; experience leading programs from late-stage development through commercial readiness and post-launch LCM strategies strongly desired.
Deep expertise in drug development across multiple functional domains including clinical development, regulatory strategy, CMC, medical affairs, and commercial readiness — rare disease experience strongly desired.
Proven track record as a decisive, strategic leader in a global matrix organization, with demonstrated ability to lead through influence rather than direct authority.
Experience leading cross-functional global program teams through major regulatory milestones, including NDA/BLA or equivalent submissions; interactions with FDA, EMA, and/or other major health authorities.
Strong business acumen with experience integrating program plans into long-range corporate strategy, portfolio prioritization, and financial planning; ability to develop and present investment cases clearly and compellingly to senior leadership.
Demonstrated ability to manage and synthesize complex scientific, clinical, regulatory, and commercial information and translate it into clear strategic direction.
Exceptional communication skills — both written and verbal — with the ability to convey nuanced scientific and strategic content to diverse audiences including executives, investors, regulators, and patient communities.
Track record of building and motivating high-performing teams, developing talent, and driving organizational alignment across complex, matrixed environments.
Global mindset with experience managing programs across multiple geographies, health systems, and regulatory jurisdictions.