Senior Director, Head of Commercialization and Patient Access

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MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. More information about the organization is available at mapspublicbenefit.com.

MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other. We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.

MAPS PBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MAPS PBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.

Position Summary

MAPS PBC is seeking an innovative mission-aligned professional with experience in late stage drug development and patient access to develop and lead the new Commercialization and Patient Access department within MAPS PBC. The Phase 3 program for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) is in progress with a New Drug Application (NDA) targeted for 2022; this would be a first-in-class drug. The first initiative is to develop the full commercial plan and support infrastructure for MDMA-assisted psychotherapy for people who suffer from PTSD, followed by plans for other indications within central nervous system disorders. Reporting directly to the Executive Director of MAPS PBC, the Senior Director, Head of Commercialization and Patient Access is responsible for providing strategic and tactical leadership and execution for all areas within the realm of commercialization including distribution, safety, Risk Evaluation and Mitigation Strategies (REMS) implementation, reimbursement, and managed care related activities. The Senior Director will maintain the primary responsibility for developing the public and private payer interface and providing internal direction of health economic projects. Suitable candidates are able to work well in a fast-paced environment, provide strategic plans, and build and manage a team. This person will also be adept at organizing and managing information virtually using required project management systems in a consistent manner.

Interested and qualified candidates are encouraged to apply online at: https://mapspublicbenefit.com/apply


Location

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet video meetings and virtual management of the department. Certain home office expenses may be reimbursed. A work computer will be provided. The MAPS PBC headquarters is located in Santa Cruz, CA. Occasional travel may be required. San Francisco Bay Area candidates are preferred.

 

Hours

Full time, exempt, salaried position. Must be available during normal business hours for a California-based company. Some night and weekend hours may be required.

 

Minimum Requirements:

• Degree requirement minimum: Bachelor’s, advanced degree such as MBA is preferred
• 10+ years of experience in the pharmaceutical industry, in the behavioral health field, ideally with exposure to treatments for PTSD
• FDA: 2+ NDAs and successful launches and/or commercialization of pharmaceuticals or biotech products
• Proven successful career progression
• Knowledge of ICH-GCP and relevant FDA and international regulations and guidelines
• Strong project management skills and experience in handling cross-functional initiatives across clinical, manufacturing, and commercial organizations
• Experience implementing and ensuring adherence to compliance requirements
• Experienced at problem analysis and developing solutions
• Strong communication and diplomatic skills with the ability to give presentations to a wide spectrum of audiences
• Ability and willingness to work “hands on” and driven to achieve goals

 

Summary of Position Duties:

• Develop and lead the new Commercial and Patient Access department within MAPS PBC
• Lead commercialization strategy efforts, bringing forward multiple options to company executives and the MAPS and MAPS PBC Boards
• Work with Regulatory Affairs and Head of Safety to develop Draft Product Label (DPL), Target Product Profile (TPP), and additional key commercialization documents to increase uptake of the treatment in the marketplace
• Evaluate commercialization options and negotiate agreements with domestic and foreign entities to scale the availability of our treatment
• Develop pricing strategy for both the drug and administration costs, including psychotherapy
• Be the outward face of MAPS PBC with regard to marketed product
• Develop commercial relationships and distribution plans
• Work with the Finance and Executive teams to ensure the commercial plan achieves financial sustainability
• Build and maintain partnerships with key stakeholders throughout the organization, commercial vendors, payers, and providers
• Contribute to the design, implementation, and monitoring of REMS Elements to Assure Safe Use (ETASU)
through robust mechanisms and compliance systems
• In partnership with the CMC Department, explore the potential for formulation changes to extend FDA-granted exclusivity
• Coordinate with the CMC Department to ensure the supply of MDMA is aligned with the forecasted demand and the growing number of available therapists over time
• Support vendor evaluation, selection, commercial drug inventory and assessment systems, and coordinate with the Safety Department for appropriate implementation for pharmacovigilance efforts and REMS implementation
• Optimize roll-out of the FDA-approved treatment based on different projected timelines for rescheduling of MDMA across U.S. states in partnership with Regulatory Affairs design and implement the commercialization timeline for additional indications to extend exclusivity
• Collaborate with relevant departments within MAPS PBC and MDMA Therapist Training initiatives to maximize coverage and reimbursement from payers in order to prioritize public benefit over profit in alignment with the special purpose of MAPS PBC

• Work closely with the company’s leadership team to create a comprehensive payer strategy and establish clear metrics of success.
• Set strategy and direction for educating and influencing key payer decision makers while promoting appropriate utilization of MDMA-assisted psychotherapy within the context of REMS programs
• Support compliance with pharmacovigilance data collection standards and operational consistency across commercial programs
• Recruit, hire, lead, and develop the commercialization team across different functions including marketing, patient access, pricing and reimbursement, sales, pharmacovigilance, etc.

 

Additional Competencies:

• Experience using Microsoft Office Applications (Word, Excel, Outlook)
• Comfortable navigating both Mac and PC operating systems
• Significant experience with video conferencing to lead effective meetings
• Able to utilize the following tools in multiple, pre-specified contexts. Prior experience a plus, some training will be provided: Smartsheet, Zoom, Asana, pharmacovigilance and drug inventory systems
• Specialty pharmacy experience is beneficial
• REMS development and management experience is beneficial
• Experience with commercializing U.S. Scheduled substances is a plus
• Experience with partnerships for global commercialization is preferred

 

FLSA Status:

Exempt / Salary

 

Compensation:

Salary available upon request, includes full benefits .

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MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.