Director, Late Stage Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement comprehensive strategies for Expanded Access Programs and late-stage studies within Definium’s portfolio.

• Direct the global strategy for Expanded Access Programs and late-stage development, ensuring alignment with asset lifecycle goals, patient access objectives, and regulatory standards.

• Collaborate with cross-functional teams to incorporate Expanded Access Program and late-stage clinical initiatives into the overall asset strategy.

• Oversee the development and execution of Expanded Access Programs, including protocol formulation, eligibility requirements, safety supervision, and operational implementation.

• Guarantee that Expanded Access Programs adhere to compliance, scalability, ethical standards, and regulatory guidelines.

• Provide consultation on benefit-risk assessments, safety monitoring, and ongoing evaluation of programs.

• Assist in the strategy for generating late-stage clinical evidence, focusing on real-world evidence, long-term safety, effectiveness, and treatment differentiation.

• Lead the design, planning, and execution of Phase 4 and investigator-initiated clinical evidence programs.

• Ensure that program designs meet regulatory commitments, payer requirements, and scientific needs.

• Collaborate on clinical content for regulatory submissions and engagements.

• Offer clinical insights for Investigator Brochures and clinical study reports.

• Work with Clinical Operations, Clinical Development, Data Management, Biostatistics, Pharmacovigilance, and Project Management to ensure high-quality execution.

• Maintain connections with investigators, advisors, and external experts.

• Provide clinical leadership within matrix teams.

⛳️ Requirements

• A doctoral degree is required (MD, PhD, PharmD, PsyD).

• 6-8+ years of clinical development experience within the pharmaceutical or biotechnology sectors.

• Proven experience in leading Expanded Access programs and late-stage, post-approval initiatives.

• Experience in selecting and managing third-party vendors to support operational aspects of Expanded Access and late-stage evidence programs.

• CNS clinical development experience in psychiatry is strongly preferred.

• Experience in budget management, including forecasting, tracking, and overseeing multiple programs.

• Familiarity with expanded access program requirements, clinical development, regulatory pathways, and lifecycle management.

• Demonstrated ability to translate strategy into execution within resource-constrained settings.

• Track record of successful cross-functional leadership and engagement with external stakeholders.

• Ability to operate with diplomacy, influence without authority, and establish credibility with senior leaders and external experts.

• Excellent verbal and written communication skills.

• Self-motivated, adaptable, and adept at balancing strategic thinking with hands-on contributions.

• Willingness to engage actively while maintaining a strategic viewpoint.

• Enthusiastic about innovation in clinical research and patient-centric access models.

• Thrives in a dynamic, fast-paced environment with high expectations of accountability.

• Acts as a role model for scientific excellence, integrity, and teamwork.

🏝️ Benefits

• 100% paid health benefits including Medical, Dental, and Vision coverage for you and your dependents.

• 401(k) program with company matching and vesting beginning after the first month post-start date.

• Flexible time off.

• Generous parental leave along with several enjoyable fringe benefits!

• Additional compensation, which may include bonuses and equity, could also be available.