Director, Clinical Development (MD required)

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.

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.

Experience 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.
• Board-certified psychiatrist preferred
• Knowledge of FDA and global regulatory requirements and guidelines (e.g., MHRA, EMA) and clinical development processes
• PREFERRED EXPERIENCE: Participating in meetings with regulatory authorities, including preparing meeting materials and meeting preparation
• Proficient knowledge of GCP/ICH, drug development process
• Experience working in a small team, fast-paced team

Key Competency Requirements

• 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
• Routinely takes initiative

Travel Required

Domestic and international travel may be required (approximately 10-25%)

Pay

The salary range for this role is $225,000 to $300,000, plus equity and benefits.