Transcendtherapeutics

Transcendtherapeutics

Director, Clinical Development (MD

New York City · Director

Sponsorship not specified$225k-$300kDetected 254 days ago
GCPClinical TrialsFDA RegulatoryCommunicationCollaborationProblem Solving

About the role

  • The Director, Clinical Development is a key member of the Clinical team, with responsibility for providing medical oversight of Transcend's clinical trials and advancing the clinical development of assigned compounds/indications.
  • This role will work closely with the clinical operations team and study sites by acting as their assigned study's medical monitor.
  • This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement.

Responsibilities

  • 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.

Requirements

  • Director, Clinical Development (MD required)
  • All other duties as required.
  • Knowledge of FDA and global regulatory requirements and guidelines (e.g., MHRA, EMA) and clinical development processes
  • Proficient knowledge of GCP/ICH, drug development process

Nice to have

  • Company Overview
  • TSND-201 was granted Breakthrough Therapy designation by the FDA based on Phase 2 results, and we have aligned on a Phase 3 program for TSND-201 in PTSD.
  • Board-certified psychiatrist preferred
  • Preferred experience participating in meetings with regulatory authorities, including preparing meeting materials and meeting preparation

Skills

  • Strong analytical and problem-solving skills, with a data driven approach to decision making.

Compensation

  • We offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.

Benefits

  • Flexible, able to pivot when needed in a fast-paced environment

Company info

  • 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.
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