Director, Late Stage Clinical Development

🕒 Agosto 26

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $215.000 - $250.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 5%

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Definium Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Definium Therapeutics é uma empresa de biotecnologia em estágio clínico, desenvolvendo terapias de precisão derivadas de psicodélicos para distúrbios psiquiátricos e neurodesenvolvimentais. A empresa foca em formulações farmacêuticas otimizadas de lisergida (LSD) e um R-enantiômero de MDMA para tratar condições como transtorno depressivo maior, transtorno de ansiedade generalizada e sintomas centrais do transtorno do espectro autista, avançando candidatos através de ensaios pré-clínicos e clínicos com uma abordagem científica e baseada em evidências.

Descrição

• Develop and execute end-to-end strategies for Expanded Access Programs and late-stage studies across Definium’s portfolio • Lead global Expanded Access Program and late-stage development strategy aligned with asset lifecycle objectives, patient access goals, and regulatory expectations • Partner with cross-functional teams to integrate Expanded Access Program and late-stage clinical activities into overall asset strategy • Lead Expanded Access Program development and implementation, including protocol development, eligibility criteria, safety oversight, and operational execution • Ensure Expanded Access Programs are compliant, scalable, ethically sound, and aligned with regulatory guidance • Consult on benefit-risk assessment, safety monitoring, and ongoing program evaluation • Support late-stage clinical evidence generation strategy, including real-world evidence, long-term safety, effectiveness, and treatment differentiation • Lead design, planning, and execution of Phase 4 and investigator-initiated clinical evidence programs • Ensure program designs address regulatory commitments, payer needs, and scientific gaps • Collaborate on clinical content for regulatory submissions and interactions • Provide clinical input into 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 relationships with investigators, advisors, and external experts • Provide clinical leadership within matrix teams

🎯 Requisitos

• 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 • 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 • 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

🏖️ Benefícios

• 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! • Additional compensation, including bonus and equity may be available