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Transcend Therapeutics · 2 months ago

Director, Clinical Development (MD required)

New York, NY

Full-time

Onsite

Lead/Staff, Director/Executive

$225K/yr - $300K/yr

5+ years exp

Transcend Therapeutics is a late-clinical-stage neuroscience company focused on developing rapid-acting treatments for neuropsychiatric diseases. The Director, Clinical Development will provide medical oversight for clinical trials and advance the clinical development of assigned compounds, working closely with the clinical operations team and study sites.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Lead the development and execution of clinical trial protocols for assigned programs, ensuring scientific rigor and regulatory compliance

Provide medical oversight for assigned clinical trials, including acting as the medical monitor

Proactively review clinical trial data to ensure patient safety and data quality

Analyze, interpret, and communicate clinical trial data to inform key decisions, providing clear recommendations to guide clinical development strategy

Contribute to authoring of key clinical documents: protocols, investigator’s brochure, clinical study reports, regulatory submissions, and publications

Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives

Support creation, review, and revision of clinical development SOPs

In collaboration with the clinical operations team, ensure that the clinical trials are conducted in a timely fashion and in compliance with SOPs, GCP, regulatory guidelines, company goals, and budget

All other duties as required

Qualification

MDEquivalentDrug development experienceFDA regulationsBoard-certified psychiatristGCP/ICH knowledgeAnalytical skillsFlexibleCommunication skillsDetail-orientedInternally motivated