Director, Late Stage Clinical Development

Scorpion Therapeutics; Durham (NC); On-site; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics in Durham, NC is seeking a senior clinical leader to drive Expanded Access Programs and late-stage CNS/psychiatry studies. You will coordinate global programs, oversee protocol design, safety, and operations, and ensure regulatory compliance and scientific rigor in collaboration with Clinical Operations, Data Management, Regulatory, and Medical Affairs.

Responsibilities include providing clinical input for regulatory submissions and engaging investigators/advisors, with a

Qualifications

• Doctoral degree (MD, PhD, PharmD, PsyD) required.
• 6–8+ years in clinical development with leadership in advanced access and late-stage programs.
• Experience in CNS or psychiatry is preferred.

Responsibilities

• Develop integrated global strategies for Expanded Access programs and late-stage studies.
• Oversee protocol design, safety, and operational implementation of access programs.
• Collaborate with Clinical Operations, Data Management, Regulatory, and Medical Affairs to ensure regulatory compliance and scientific rigor.
• Provide clinical input for regulatory submissions and external stakeholder engagement.

Skills

Cross-functional leadership

Regulatory strategy

Vendor management

Clinical development

Education

Doctoral degree (MD, PhD, PharmD, PsyD)

Job description

Role

Lead the development and execution of strategies for Expanded Access Programs and late-stage clinical studies within a psychiatric biopharma context, focusing on psychedelics and neuropsychiatric therapeutics.

Responsibilities

develop integrated global strategies, oversee protocol design, safety, and operational implementation of access programs, and support evidence generation for post-approval indications. Collaborate across functions such as Clinical Operations, Data Management, Regulatory, and Medical Affairs to ensure regulatory compliance, scientific rigor, and alignment with lifecycle management goals. Provide clinical input for regulatory submissions and external stakeholder engagement, including investigators and advisors.

Requirements

Doctoral degree (MD, PhD, PharmD, PsyD); 6-8+ years in clinical development, with proven experience in leading advanced access and late-stage programs-preferably in CNS or psychiatry. Skills include knowledge of regulatory pathways, lifecycle management, vendor management, and cross-functional leadership.

Preferred

CNS clinical development experience. High-Value: focus on psychiatric indications such as generalized anxiety, MDD, PTSD, and ASD; oversight of Phase 4 and post-approval studies; deep understanding of real-world evidence and regulatory strategy.

WorkSetup

Not specified.