Full Time
Remote
Posted 2 weeks ago

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. 

CMC Senior Manager Executive Summary 

Reporting to the Head of CMC, the CMC Senior Manager will lead the CMC clinical supply team in ensuring that clinical and commercial drug supplies are forecasted, manufactured, and distributed in accordance with program timelines. This involves supervising and guiding IMP (Investigational Medicinal Product) supply managers. This candidate will provide oversight of IMP supplies through strategic leadership and operational management of cross-functional projects. This experienced leader will be responsible for ensuring that projects are planned and implemented on time and on budget. A high compliance standard will be maintained in all related CMC activities. The initial focus will be on enabling studies for filing an NDA submission in 2023.

The CMC Senior Manager will strengthen logistics capabilities by serving as an expert resource, identifying and disseminating best practices from their industry experience, and providing mentoring and training

Key Responsibilities 

  • Lead CMC Supply Team: manage IMP supply, personnel, and other resources across projects. Mentor junior staff and establish shared norms, best practices, and tools across CMC.
  • Lead CMC Projects: align teams around clearly defined goals, priorities, and timelines. Maintain CMC logistics plans across the programs with clear milestones, and deliverables. Coordinate communication, activities, and maintain accountability.
  • Lead Process Improvement: identify opportunities to accelerate progress and gain efficiencies by proactively identifying resource constraints, facilitate prioritization, and resource allocation. Establish efficient and effective clinical supply processes and systems.

Minimum Requirements 

What you bring to the role: 

  • Bachelor’s degree in a bio-medical, science or related field
  • At least 5 years of experience working in drug development
  • At least 2 years of clinical supply management experience
  • Ideal candidate would have a proven track record of clinical trial supply and/or commercial supply management, preferably from a CRO (Contract Research Organization) or CDMO environment
  • Supervisory experience leading a team
  • Project management skills relevant to drug development and/or commercialization
  • Familiarity with GxP
  • 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!

Job Features

Job Category

Scientific

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