Clinical Trial Leader - Remote Position

Clinical Operations · Any City, Any State, California
Department Clinical Operations
Employment Type Full-Time
Minimum Experience Experienced

About MAPS Public Benefit Corporation (MAPS PBC)

 

MAPS PBC catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics. We are currently focused on developing MDMA-assisted therapy as a Breakthrough Therapy for PTSD, with plans to submit for FDA approval in 2023. The results of our successful pivotal Phase 3 clinical trial were recently published in Nature Medicine and profiled on the front page of The New York Times

 

Founded in 2014, MAPS PBC is a Public Benefit Corporation that prioritizes public benefit over profit. We are a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics.

 

 

Why work for MAPS Public Benefit Corporation (MAPS PBC)?

  • We are a diverse team that shares a deep belief in the critical importance of our work and its potential to change the world.
  • We are pioneering a new kind of pharmaceutical company that prioritizes public benefit and is committed to sustainability, accountability, and transparency.
  • We are conducting high-quality scientific research at the cutting edge of psychiatry. We are committed to open science and regularly publish in leading academic journals.


Clinical Trial Leader Executive Summary

Reporting to the Clinical Program Manager, the Clinical Trial Leader is responsible for implementation and operational management and oversight of clinical studies at MAPS PBC. The CTL plays a central role in ensuring clinical trials are conducted in a timely manner, 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 right candidate will have a passion for clinical research in novel therapeutics and a proven track record of successfully managing clinical trials within established timelines and budget. 

 

Key Responsibilities

  • Study design, implementation, oversight, and reporting: work cross-functionally to support successful study design and the operationalization of clinical study protocols from conception and regulatory approval through database lock and clinical study reporting. Includes responsibilities such as protocol development, amendments, task management, training, supply coordination, budgeting support, etc.
  • Best-in-class research oversight: ensure that all clinical trials follow the principles of ICH/Good Clinical Practice and are conducted according to the protocol and highest research standards.
  • Team leadership: mentor and help task manage CRAs and CSAs. Foster effective team communication and collaboration, providing honest and actionable feedback when relevant.


Minimum Requirements

What you will bring to the role:

  • 8+ years of CRA or equivalent experience
  • Biomedical scientific degree or relevant experience, with a strong interest in clinical research
  • Knowledge of medical practice/techniques and terminology
  • Knowledge of clinical research study design and process, as well as U.S. regulations governing 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. 

 

MAPS PBC commits to building a supportive, equitable, and accessible workplace. We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, arrest or conviction record, military and veteran status, religions, abilities, and perspectives.

Thank You

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  • Location
    Any City, Any State, California
  • Department
    Clinical Operations
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced