Associate Director, Clinical Operations

Position Details Title: Associate Director, Clinical Operations Location: New York City preferred (we’re open to remote arrangements for exceptional candidates) 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 Associate Director (AD), Clinical Operations is a key member of the Clinical Operations team, with responsibility for overseeing the execution of Transcend’s clinical trials. The AD will help drive trial operational strategy. The AD will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by a Senior Director, Clinical Operations when needed. This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement. A successful AD is forward thinking, takes initiative, and leads with the end in mind. This position will report to the Senior Director, Clinical Operations. Key responsibilities will include: Support the Clinical Trial Manager with planning and strategy for implementation and execution of assigned clinical trials from study startup through close-out Oversee day-to-day operations of assigned clinical trials including team interactions with study sites and vendors and act as an escalation point for key issues Identify, prepare, and implement departmental process improvement initiatives to improve operational efficiencies Provide expertise for drafting, finalization and implementation of clinical documents (ie, Protocol, Clinical Monitoring Plan) Oversee various activities and cross-functional collaboration of assigned clinical trials (e.g., monitoring, data management, drug supply logistics, labs, recruitment) Manage direct report(s) by providing leadership, vision and mentoring Proactively identify clinical data trends and escalate as needed Ensure Trial Master File (TMF) maintains regulatory compliance Support creation, review, and revision of clinical SOPs 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 $180,000 to $210,000, plus equity and benefits. Experience Requirements Bachelor’s degree, preferably in a life science At least 7 years of clinical trial experience within a pharmaceutical company or CRO and at least 4 years in a managerial position Experience managing direct reports Proficient knowledge of GCP/ICH, drug development process, clinical operations Experience executing clinical trials in a small team or at a small pharmaceutical company is preferred Experience conducting studies in psychiatry-related indications is preferred Previous clinical monitoring experience is preferred Key Competency Requirements 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 Able to effectively communicate and collaborate across functions and job leve