Associate Director, Clinical Development – MDD

🕒 Abril 21

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Definium Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🧬 Biotecnologia

💊 Farmacêutico

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

• Serve as a responsible member and clinical science representative on global development teams • Collaborate with cross‑functional partners to provide clinical development expertise in support of study execution • Provide therapy‑area medical and scientific expertise in the evaluation and presentation of clinical trial data • Write and edit clinical protocols, clinical study reports, manuscripts, and other study‑related documents • Support the quality, coordination, and timeliness of clinical sections of regulatory deliverables (e.g., INDs, Investigator Brochures, CTAs, ISS/ISE, clinical expert reports) in partnership with Regulatory Affairs and Project Management • Review and monitor patient‑level and study‑level data, including participation in blinded data review and use of data science approaches as applicable • Collaborate with statisticians and programmers on statistical analysis plans and interpretation of clinical data • Work with Medical Writing to support abstracts, manuscripts, and presentations for external scientific meetings • Act as the clinical science lead to CROs and external vendors, with appropriate oversight from senior leadership • Contribute to a culture of innovation, collaboration, and continuous improvement • Perform additional responsibilities as assigned by leadership

🎯 Requisitos

• Doctoral degree required (PhD, MD, PharmD, PsyD, MA, LCSW) • Minimum of 3 years of clinical development experience • Experience in CNS development (psychiatry or neurology) strongly preferred • Strong understanding of late‑stage clinical development and regulatory processes • Experience in data review, analysis, and regulatory writing (e.g., IND and CTD sections) • Demonstrated ability to work collaboratively across functions • Excellent written and verbal communication skills.

🏖️ 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!