Full Time
Remote
Posted 1 month 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. 

Head of Medical Science and Safety, Senior Medical Director Executive Summary

The Head of Medical Science and Safety, Senior Medical Director will report to the Chief Medical Officer in the Clinical Development Department and will be responsible for the direct reporting of all Medical Monitors and oversight of all clinical trial needs. They will partner seamlessly with Clinical Operations, Data Management, Regulatory, Biostatistics and other development functions to ensure successful development program delivery. As a leader in the organization, the candidate will be involved in clinical program strategy and help assure that activities are executed within expected scope, budget and timelines.

Key Responsibilities

  • People manager: The Head of Medical Science and Safety, Senior Medical Director will have excellent leadership skills. They will provide direct oversight of 6 Medical Monitors and indirect oversight of 2 Safety Associates and 2 Interns.
  • Managing timelines and studies: The Head of Medical Science and Safety, Senior Medical Director will provide leadership support for all MPBC sponsored studies assuring high quality safety oversight while managing critical timelines and assessing internal resources and competing priorities for the team.
  • Collaborate with Clinical Operations and other stakeholders: The Head of Medical Science and Safety, Senior Medical Director will collaborate with Clinical Operations and other departments within MPBC to continue Process and Governance improvements, prepare the organization for inspection readiness and support the organization as it continues to expand.
  • Act as a champion for high standards: Head of Medical Science and Safety, Senior Medical Director maintains high standards of compliance, ethics and safety, and putting safety of study participants first.

Minimum Requirements

What you bring to the role:

  • MD or MD/PhD and 7+ years of industry clinical development experience.
  • 3+ years’ experience leading cross-functional teams and management experience.
  • Track record of excellence in people management.
  • Demonstrated excellence and experience in early and late-stage clinical development preferably in psychiatric indications.
  • Experience overseeing the development of study protocols and clinical study reports, study medical monitoring, safety reporting, clinical-regulatory and quality documents.
  • Independent, able to hit-the-ground running with minimal instruction.
  • Works well in a team environment both as a leader and a key contributor.
  • Demonstrated success in engaging regulatory approval agencies at critical time points with NDA/BLA submission experience preferred.
  • Post-Marketing clinical development or drug safety experience is a plus.
  • Proven ability to develop internal relationships, as well as external relationships with clinical sites and Key Opinion Leaders.
  • 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

Medical

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