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.
Senior Director, Clinical Development
Reporting directly to Head of Development, the Clinical Development Senior Director is responsible for working cross-functionally to oversee the design and development of Phase 1-3 clinical trials. The Clinical Development Director must be highly innovative and take bold steps to generate clinical data by designing well-powered, data-rich studies that significantly reduce the time it takes to bring medicines to patients, control costs & boost efficiency without compromise on quality and safety. A key component is scientific engagement with external partners and stakeholders, such as clinical investigators, clinicians, scientists, and key external experts (KEEs).
You will drive the design of clinical trials, development of protocols, and other study and regulatory-related documents for all clinical programs. This includes:
- Study design and protocol development
- Data oversight and ongoing benefit:risk assessment
- Analytic guidance and data interpretation
- Manuscript planning and execution
You will manage a growing team of clinical researchers. You will partner seamlessly with Clinical Operations, Clinical Science, Data Management, Regulatory, Biostatistics and other development functions to ensure successful development program delivery. As a senior leader in the Development organization, you will be involved in clinical program strategy development, facilitate ongoing process improvement efforts and ensure high quality medical and safety oversight for our study participants.
Design and execution of clinical trials
- In conjunction with other relevant functional areas, provide clinical science leadership to guide the Integrated Development Plan (IDP) and Lifecycle Plans (LCPs).
- Responsible for ensuring the Go/No-Go criteria have been set for the study.
- Ensure that all protocol documents are high quality and align with the CDP to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
- Participate in the analysis and interpretation of data, assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts.
Support engagement with regulatory agencies
- Works with regulatory and other internal and external partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
- Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirements, including scientific advice, IND, EoP2, pre-NDA meetings, NDA and MAA documents.
GCP, Quality, and Inspection-Readiness
- Ensures compliance with SOPs, ICH, GCP and other national and international regulatory requirements.
- Ensure that processes and practices within Clinical Development and Data align with quality standards; with support of QA, drive continuous improvement of operations and ensure inspection-readiness; as needed, work with QA to co-lead both site and sponsor inspection preparations.
Internal and external clinical thought leader
- Maintain scientific and clinical knowledge in relevant therapeutic and disease areas and provides scientific input across MPBC, as needed.
- Engage and influence a diverse scientific community of internal and external experts and collaborators, including the formation and management of expert advisory groups.
Patient-centricity with inclusive mindset
- Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first
- Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
- An MD (or equivalent) and Board Certification; Psychiatrist preferred (or adjacent – e.g., neuro)
- 7+ years leading Development functions including at least 5 years managerial experience in high-performing biopharma organization or biopharma business unit of at least 100 FTEs (i.e., Including leadership of Clinical Operations, Clinical Science / Medical / Safety, and Data Management / Biostatistics)
- Demonstrated ability to evaluate, interpret, and present complex scientific data, deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
- Extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles
- Demonstrated expertise across all major dimensions of clinical development, including development strategy, trial design, study medical monitoring, safety reporting, trial execution, clinical study reports.
- Demonstrated success leading both early- and late-stage development, preferably having taken multiple assets through NDA approval with a proven publication track record.
- Demonstrated success in managing organizational growth and transformation; a builder who thrives in a fluid, fast-paced environment.
- International experience and perspective a plus, notably Europe, US, Canada.
- Superb communicator and relationship-builder experienced in engaging with internal stakeholders (e.g., Executive Committee through entry-level staff) and external stakeholders (e.g., site investigators and staff, regulators and Key External Experts)
- Executive presence, confidence, maturity, EQ, and interpersonal skills to build strong internal and external multi-national, cross-functional engagement.
- Mission driven; someone who shares passion for making a difference in human health and wellbeing.
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)
Employer paid medical, dental, vision, and life insurance (100% covered for employees + 50% for dependents)
Employer funded mental health HRA
Employer funded SEP IRA
Home Office Stipend
Conscious culture offering guided meditations, yoga and psychedelic ecosystem dialogues