Senior Associate, Clinical Operations

Position Details Title: Senior Associate, Clinical Operations Location: New York City 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 Senior Associate, Clinical Operations is a key member of the Clinical Operations team, with responsibility for supporting the operational aspects of one or more clinical trials. The Senior Associate will support the Clinical Trial Manager, CRAs, and the investigational sites. This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement.  Key responsibilities will include: Assist clinical team during all phases of a clinical study (feasibility, start-up, maintenance, and close-out) Support field-based clinical research associates Participate in vendor and study team meetings, including drafting meeting minutes, as needed Collect and review essential regulatory documents Submission and tracking of documents to central IRB Distribute materials to study sites, as directed Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment) Review and maintain documents in the Trial Master File (TMF) Support internal data review, as needed Participate in creation, review, and revision of clinical SOPs Assist in preparation and coordination of Investigator Meetings, as needed Additional responsibilities 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 $70,000 to $100,000, plus equity and benefits. Experience Requirements At least 1 year of clinical research experience within a pharmaceutical company or CRO or at least 3 years of experience as a clinical research coordinator Experience in conducting studies in psychiatry-related indications is preferred Proficient knowledge of GCP/ICH, drug development process, clinical operations 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 effectively communicate and collaborate across functions and job levels Internally...