Full Time
Remote
Posted 2 months ago

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. 

Director Clinical Operations Executive Summary

The Director Clinical Operations will provide strategic operational guidance, management and execution across Clinical Operations in support of MAPS PBC’s clinical programs. This person will ensure the highest standard of clinical operational excellence in accordance with contractual agreements, SOPs, federal and state regulations, GCP and ICH guidelines. The Director/AD Clinical Operations will be instrumental in leading the Clinical Operations team towards approval of a first-of-its-kind MDMA-guided treatment for PTSD, and programs to follow.         

Key Responsibilities

Program Planning and Management – Oversee, drive and monitor operational management of clinical programs. Proactively ensure study timelines, deliverables and budgets are met in coordination with Project Management, study leads, Finance and Contracts accordingly. 

SOP & System Development and Management – Contributes to quality initiatives and provide input to clinical systems coordinating with the Systems and Quality Manager, including assisting with audit planning and inspection readiness initiatives. Identifies and proposes process and system improvements to maintain quality and effective deliverables.

People Management – Responsible for hiring, managing and cultivating career development of clinical operations team FTE and contract staff. 

Resource Allocation and Vendor Management – Strategically and proactively assess and address resource needs across different areas of clinical operations as they arise.

Cross-functional Representation:  Communicate executive-level guidance, key study and program metrics at the team level as well as to area sub-teams, committees and relevant stakeholders.  Serve as the escalation point for clinical operations issues that impact overall study or program timelines, other functions, budget or quality. Lead cross-functional team initiatives for continuous improvement projects.

Minimum Requirements

What you bring to the role:

  • BS or BA in Life Science or relevant discipline
  • At least 12 total years of clinical research experience within pharma/CRO
  • At least 5 years in a similar leadership role AD/Director level (direct staff management in CRO/Pharma)
  • Strong track record in leading clinical trial operations and teams under GCP/ICH Guidelines among other applicable regulatory agencies.
  • Experience with regulatory activities in the US and EU, as well as direct experience with FDA readiness
  • Track record of achievement in successful planning & execution of previous clinical studies
  • A strong desire to improve the quality of life for individuals, catalyzing healing and well-being through psychedelic drug development  
  • Previous CRA experience a plus
  • Experience in international trial conduct and management, a plus  
  • Computer skills with the ability to use the following tools with some training (previous experience a plus):  Microsoft Office (Word, Excel, Powerpoint, Outlook, Sharepoint), Smartsheet, Zoom and Asana
  • Able to work efficiently in a remote virtual setting
  • Courage to be an “out-of-the-box” thinker, to take on calculated risks, and champion of new ideas and approaches 

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

Clinical, Director

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