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Executive Director, Late Stage Clinical Strategy

1 day, 21 hours ago
Anywhere
Full-time
Executive
Program Manager
Project and Program Management
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 18

Description

  • Own and lead 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 CMO, Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy, and Program Leadership to integrate EAP and late-stage activities into overall asset strategy and the Target Product Profile.
  • Serve as the clinical development lead for governance discussions related to post-approval and access strategies, including risks, trade-offs, and recommendations.
  • Design and implement Expanded Access Programs, including protocol development, eligibility criteria, safety oversight, and operational execution.
  • Lead cross-functional planning to ensure Expanded Access Programs are compliant, scalable, ethically sound, and aligned with regulatory guidance.
  • Provide clinical leadership for benefit-risk assessment, safety monitoring, and ongoing program evaluation.
  • Define phase 4 objectives and lead the design, planning, and execution of potential phase 4 studies, including real-world evidence generation, long-term safety, and effectiveness.
  • Lead late-stage study planning and execution, including protocol development, data collection strategies, and interpretation of outcomes.
  • Ensure late-stage and potential phase 4 program design addresses regulatory commitments, payer needs, and scientific gaps.
  • Lead preparation and review of clinical content for regulatory submissions and interactions, and oversee clinical input into Investigator Brochures and clinical study reports.

Requirements

  • Doctoral degree required, such as MD, PhD, PharmD, or PsyD.
  • 10+ years of clinical development experience in the pharmaceutical or biotechnology industry.
  • Demonstrated experience leading late-stage, post-approval, Expanded Access, or other later-stage programs.
  • CNS development experience in psychiatry or neurology strongly preferred.
  • Experience in small-molecule development preferred.
  • Deep understanding of 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.

Benefits

  • Starting base pay range of $248,140.00 to $296,656.00 per year.
  • Additional compensation may include bonus and equity.
  • 100% paid health benefits, including medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match and vesting after the first month.
  • Flexible time off.
  • Generous parental leave.
  • Competitive employee benefits and fringe perks.

Interested in this position?

Apply directly on the company website

Apply Now

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