Director, Clinical Development (MD required)

Director, Clinical Development (MD Required)

New York City preferred (remote arrangements may be considered)

Company Overview

Founded in 2021, Transcend Therapeutics is a late-clinical-stage neuroscience company developing rapid-acting treatments for neuropsychiatric diseases. Our lead asset TSND-201, a rapid-acting neuroplastogen, is the first and only product to demonstrate rapid, robust, and durable therapeutic effects in PTSD. 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. Transcend is backed by leading life sciences investors and driven by a mission to create treatments for the millions of people for whom current psychiatric medicines have not worked.

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. 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.

Key responsibilities will include:

• 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.

This is a great opportunity to step into a high-impact, high-visibility role on the early team of Transcend Therapeutics. We offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.

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

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%)

We are committed to building a diverse, inclusive and talented team, free from discrimination. If you're excited about our mission but don't meet 100% of the qualifications above, we encourage you to apply.

Transcend Values

Operate with good intent. Above all, we aim to reduce suffering. We must remain selfless in pursuit of that noble goal, acting with good intent and assuming the same in our partners and peers.

Proceed with passion. We're working to usher in an era where people with mental illness have safe and easy access to the treatments they need. Fulfilling that mission demands creative ideas, camaraderie among collaborators, and an understanding that we are all responsible for our individual and team success.

Be willing to work—and learn—together. The problems we're working to solve are complex, and no one person has every solution. Making the best decision as a team is more important than being individually 'right.' The diversity of our backgrounds and experiences is a strength; when all of those views are synthesized, we can develop new solutions and make better decisions.

Stay focused and flexible. Resourcefulness plays a major part in our success; we can't let unexpected set-backs derail our progress. Think creatively, act ethically, and find a way to get it done.