Director, Clinical Development (MD required)

Transcend Therapeutics•New York City, NY

18d•$225,000 - $300,000•Remote

About The Position

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. A successful candidate is forward thinker, who takes initiative, and leads with the end in mind. This position will report to the Sr. Vice President, Clinical Development.

Requirements

MD or equivalent with 5+ years drug development experience in a pharmaceutical company, with 2+ years’ experience in neuroscience-related indications.
Candidates with relevant experience in academia, or a related environment may be considered
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
Experience working in a small team, fast-paced team
Strong analytical and problem-solving skills, with a data driven approach to decision making.
Excellent verbal, written, communication and interpersonal skills
Detail-oriented, with a desire to ‘get in the weeds’ and understand the nuances
Flexible, able to pivot when needed in a fast-paced environment
Able to align with company goals and focus on the big picture
Internally motivated, with a passion for mental health

Nice To Haves

Board-certified psychiatrist preferred
Preferred experience participating in meetings with regulatory authorities, including preparing meeting materials and meeting preparation

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.