IIT/IIR Program Manager

Remote (United States)

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 Therapyby 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. 


IIT/IIR Program Manager Executive Summary


The IIT/IIR Program Manager (PM) will report to the Head of Medical Affairs and will be responsible for

managing, implementing and maintaining oversight of MAPS PBC’s Investigator-Initiated Trial

(IIT)/Investigator-Initiated Research (IIR) program. The PM oversees and upholds standards for the IIT

program, ensuring process adherence to MAPS PBC Standard Operating Procedures (SOPs), International

Council for Harmonisation (ICH)/Good Clinical Practice (GCP), and all applicable regional and local

regulations. The PM directly manages IIT/IIR program staff and coordinates cross-functional teams to

support program execution.



Key Responsibilities


  • Program Strategy: Oversee MAPS PBC’s IIT/IIR program strategy, optimizing processes and procedures to ensure effective cross-functional communication and program adherence with MAPS PBC’s scientific objectives and research priorities. Implement process rigor including acceptance criteria, fair market value assessments, and adherence to regional regulatory and review board requirements.


  • Program Execution: Manage a team to execute the IIT/IIR program and serve as liaisons between investigators and MAPS PBC leadership throughout the entire study process, from concept submission to study completion. Manage the IIT/IIR review process including coordination of input from designated subject matter experts and the IIT Committee, taking an active part in evaluating submitted concepts and protocols. Facilitate contracting processes and coordination of investigational medicinal product (IMP) supply planning including regional logistics of importing/ordering with cross-functional collaborators as appropriate for each protocol.



Minimum Requirements


  • Bachelor’s Degree with 3+ years in pharmaceutical or life sciences industry.
  • Experience overseeing IIT/IIR programs.
  • Experience serving as a clinical study coordinator or site manager preferred.
  • Experience leading projects that involve cross-functional teams and external collaborators.
  • Experience managing teams preferred.
  • Experience in CNS preferred.
  • Highly effective verbal & written communication skills.
  • Strong ability to work in a remote environment.
  • Ability to effectively manage multiple projects and competing timelines.
  • Understanding of ICH/GCP guidance as related to clinical trials.


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

Conscious culture offering guided meditations, yoga and psychedelic ecosystem dialogues

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