Director, Late-Stage Clinical Strategy

The Director, Late-Stage Clinical Strategy will be responsible for the end-to-end strategy development, design, and execution of Expanded Access Programs and Late-Stage studies across Definium's portfolio. This leader will provide support to ensure programs are scientifically sound, operationally feasible, regulator-ready, and aligned with the integrated asset strategy, including lifecycle management, real-world evidence generation, and post-approval commitments.

This role requires both strategic leadership and hands-on execution, with the ability to operate effectively in a lean, fast-moving organization.

Responsibilities

Strategic Leadership

• Lead aspects of the global strategy for Expanded Access Programs and Late-Stage development, aligned with asset lifecycle objectives, patient access goals, and regulatory expectations
• Partner with the Executive Director Late-Stage Clinical Strategy, Clinical Development, Clinical Operations, HEOR, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead and Program Leadership to ensure Expanded Access Program and Late-Stage clinical activities are fully integrated into the overall asset strategy

Expanded Access Program Execution

• Lead the development and implementation of Expanded Access Programs, including protocol development, eligibility criteria, safety oversight, and operational execution
• Collaborate with cross-functional planning team to ensure Expanded Access Programs are compliant, scalable, ethically sound, and aligned with regulatory guidance
• Provide consultation to benefit-risk assessment, safety monitoring, and ongoing program evaluation

Late-Stage Strategy & Execution

• Support the development of the late-stage clinical evidence generation strategy objectives, including real-world evidence generation, long-term safety, effectiveness, and differentiation in the treatment landscape
• Lead the design, planning, and execution of the late-stage clinical evidence program, including protocol development, data collection strategies, and interpretation of outcomes for Phase 4 and investigator-initiated trials.
• Ensure late-stage clinical program designs address regulatory commitments, payer needs, and scientific gaps

Regulatory & Scientific Leadership

• Collaborate in the preparation and review of clinical content for regulatory submissions and interactions as applicable
• Provide clinical input into Investigator Brochures, clinical study reports, in collaboration with Regulatory Affairs

Cross-Functional & External Engagement

• Work collaboratively with Clinical Operations, Clinical Development, Data Management, Biostatistics, Pharmacovigilance, and Project Management to ensure high-quality execution
• Establish and maintain relationships with key investigators, advisors, and external experts to support EAP and late stage/potentially Phase 4 objectives
• Provide clinical leadership within matrix teams, modeling accountability, collaboration, and scientific rigor

Qualifications

Education & Experience

• Doctoral degree required (MD, PhD, PharmD, PsyD)
• 6-8+ years of clinical development experience in the pharmaceutical or biotechnology industry
• Demonstrated experience leading Expanded Access programs and late-stage, post-approval programs
• Experience selecting and managing third-party vendors to support operational functions of Expanded Access and late-stage evidence programs
• CNS clinical development experience in psychiatry strongly preferred
• Experience with budget ownership to include forecasting tracking, and managing across multiple programs

Skills & Competencies

• Working knowledge of expanded access program requirements, clinical development, regulatory pathways, and lifecycle management
• Proven ability to translate strategy into execution in resource-constrained environments
• Track record of effective cross-functional leadership and external stakeholder engagement
• Ability to operate with diplomacy, influence without authority, and command credibility with senior leaders and external experts
• Excellent verbal and written communication skills
• Self-motivated, adaptable, and comfortable balancing strategic thinking with hands-on contribution

Mindset & Fit

• Comfortable rolling up sleeves while maintaining a strategic perspective
• Energized by innovation in clinical research and patient-centric access models
• Thrives in a fast-paced, evolving environment with high accountability
• Acts as a role model for scientific excellence, integrity, and collaboration