Senior Clinical Trial Manager at Definium Therapeutics

Job description

Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward—beyond better, into a boundless future. Join us! The Senior CTM role sits within the Clinical Operations Department at Definium Therapeutics and provides site and/or country level management as well as vendor/external service provider oversight and management. As a Senior CTM, this role may be assigned as the Clinical Operational Trial Lead on a clinical trial, with oversight by the Senior Director/Executive Director of Clinical Operations within the organization. The role provides operational oversight at the site level and/or country level (for larger late phase trials) and is responsible for oversight and management of external service providers/vendors, ensuring high-quality deliverables, within agreed upon timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The Senior CTM, if assigned as the Clinical Operations Trial Lead for a trial, is responsible and accountable for ensuring successful cross-functional delivery of the trial, with scope from draft protocol synopsis to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results. The Senior CTM, whether managing site/country and vendors or as the Clinical Operational Trial Lead, will ensure ongoing inspection readiness, data integrity and overall data quality according to and in compliance with corporate and project/program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations. The Senior CTM role will assist in the development and review of Clinical Operations Department SOPs, Plans and Systems build. In addition, will lead process improvement initiates, create processes not currently in place, including the creation of site/trial management tools. For outsourced trials to a CRO, this role will serve as a key liaison with oversight and delivery of the transferred obligations and responsibilities. Responsibilities: Utilize Definium’s or CRO systems (when outsourced) to review Monitoring Visit Reports, monitoring visit scheduling, monitoring metrics, protocol deviations, issues, and action items to ensure data quality Serve as Sponsor contact for external service providers/vendors with overall responsibility ensuring deliverables are executed with high quality and within timelines and budget Oversees and tracks CRO/Vendor partners to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed Maintain therapeutic knowledge and familiarity with clinical protocol(s) and project(s) as appropriate Work with CRO/Vendors to revise