About MAPS Public Benefit Corporation (MAPS PBC)
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 or 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.
Independent Rater Program Lead Executive Summary
Reporting to the Director of Clinical Operations, the Independent Rater Program Lead ensures that clinical trials are conducted in a timely manner and 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 IRPL is responsible for providing centralized support to clinical team members, assisting with site communications, data review, report writing, coordinating aspects of the specialized pools of raters, creation and support of rater documents and policies, invoice processing, essential document review and tracking. The IRPL has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s). The focus of the IRPL is to facilitate operations of the Independent Rater program across trials, along with contributing to clinical documents, reviewing and cleaning data, and contributing to clinical operation documents (e.g. SOPS, work instructions.)
- Lead IR Program. Run day to day operations for our independent rater program with coordination, management, and support for pools of specialized raters. Implement SOPs, agreements, and strategies to develop process improvements with creative solutions.
- Collaborate Cross Functionally. Conduct and contribute to cross functional team meetings by facilitating the exchange of information within Clinical Operations and with MAPS PBC staff. Liaise with doctors, therapists, and investigators involved in the studies.
- Manage Rater Pool. Conduct recruitment, reviews, onboarding, and assurance of training appropriately qualified independent raters. Provide proactive planning for and discussion of enrollment timelines and subsequent IR workload.
What you bring to the role:
- A bio-medical related scientific degree or relevant experience with a strong background in clinical research. Minimum of bachelor’s degree preferred.
- Knowledge of project relevant medical practice/terminology.
- Proficient knowledge of clinical research study design and process.
- Knowledge of U.S. regulations governing clinical trials, demonstrated ability to adhere to GCP and regulatory standards.
- Demonstrated experience preparing, gaining approval, and managing clinical protocols and procedures.
- 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!