MAPS PBC is pioneering a new form of mental health care, beginning with the development of MDMA-assisted therapy as an FDA-approved treatment for PTSD. MDMA-assisted therapy is a new paradigm in the treatment of mental health, combining a medicine with psychotherapy to address the root causes of PTSD. It has been designated a Breakthrough Therapy by the FDA and the results of our pivotal Phase 3 clinical trial were published in Nature Medicine and profiled on the front page of The New York Times.
MAPS PBC is a Public Benefit Corporation, with a dual mandate to generate shareholder value and public benefit. We are a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics. We are committed to continuing to lead the field of psychedelic medicine with integrity and ethics at the core.
Why work for MAPS Public Benefit Corporation (MAPS PBC)?
- We are a diverse team that shares a deep belief in the critical need for innovation and expanded access in the treatment of mental health conditions.
- We are entrepreneurial, collaborative, and open-minded in how we approach our innovative work.
- We are a new kind of pharmaceutical company that prioritizes public benefit over profit and is committed to sustainability, accountability, and transparency.
We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment.
Clinical Trial Leader Executive Summary
Reporting to the Clinical Program Manager, the Clinical Trial Leader is responsible for implementation and operational management and oversight of clinical studies at MAPS PBC. The CTL plays a central role in ensuring clinical trials are conducted in a timely manner, in accordance with standard operating procedures (SOPs), the principles of ICH/Good Clinical Practice, and all applicable regulations governing the conduct of clinical trials. The right candidate will have a passion for clinical research in novel therapeutics and a proven track record of successfully managing clinical trials within established timelines and budget.
- Study design, implementation, oversight, and reporting: work cross-functionally to support successful study design and the operationalization of clinical study protocols from conception and regulatory approval through database lock and clinical study reporting. Includes responsibilities such as protocol development, amendments, task management, training, supply coordination, budgeting support, etc.
- Best-in-class research oversight: ensure that all clinical trials follow the principles of ICH/Good Clinical Practice and are conducted according to the protocol and highest research standards.
- Team leadership: mentor and help task manage CRAs and CSAs. Foster effective team communication and collaboration, providing honest and actionable feedback when relevant.
What you will bring to the role:
- 8+ years of CRA or equivalent experience
- Biomedical scientific degree or relevant experience, with a strong interest in clinical research
- Knowledge of medical practice/techniques and terminology
- Knowledge of clinical research study design and process, as well as U.S. regulations governing clinical trials
- Cover letter required; incomplete applications may not be considered.
MAPS PBC is a distributed team that uses technology and periodic in-person gatherings to stay connected. We look for people who are comfortable with and skilled at remote work and collaboration.
Competitive benefit package includes:
- Paid Time Off (PTO)
- Sick Time
- Holiday Pay
- Employer paid medical, dental, vision, and life insurance (100% covered for employees + 50% for dependents)
- Employer funded mental health HRA
- Employer funded SEP IRA
- FSA/Dep Care
- Pet Insurance
- Home Office Stipend
- Wellness Wednesday/Journal Club/Yoga/Meditation and so much more!