Director, Late Stage Clinical Development

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

The starting base pay range for this position is $215,000.00 - $250,000.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave and some fun fringe perks!