Senior Clinical Trial Manager
Definium Therapeutics · Remote · Remote · $160k–$190k
Posted by Definium Therapeutics on their careers site · View the original posting
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Senior · asks for 6+ years
Open 15 days
The posting, as Definium Therapeutics wrote it
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 imp
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am operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality oversight of assigned trial utilizing the available tools
- Ensures trial team members have received the appropriate trial-specific training needed for their function; in collaboration with the study clinician, ensures appropriate trial-specific training is given to trial team members and/or to the CRO
REQUIREMENTS
- BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 6 years clinical trial experience in the pharmaceutical industry or CRO
- Experience with managing clinical trials or prior experience in a senior CRA role, ideally in the psychiatric space
- Willingness and ability to travel up to 20% of the time, defined by business needs
- This position requires strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced and dynamic environment
- Requires clinical research operational knowledge, project planning/management, communication, and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experience managing teams in a virtual environment is required.
- Experience in vendor management strongly preferred
- Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness
Individual compensation within the range is determined based on factors such as relevant skills, experience, qualifications, scope of the role, and other legitimate business considerations. In addition to base salary, this role may be eligible for bonus and equity opportunities. We also offer a comprehensive benefits package including health insurance, 401(k) with company match, flexible time off and additional wellness benefits and perks. Learn more about our benefits on our Careers page.