We're looking for a candidate to fill this position in an
Lead commercialization strategy, bringing forward multiple
options to leadership in alignment with the Public Benefit Mission,
with a focus on building internal competencies for Go to Market
Evaluate commercialization options and negotiate agreements with
domestic and foreign entities to scale the availability of
treatment for market size and uptake.
Optimize roll-out of the FDA-approved treatment with
consideration for projected timelines of rescheduling of MDMA
across US states to ensure market penetration.
Work with Regulatory Affairs and Head of Safety to develop Draft
Product Label (DPL), Target Product Profile (TPP), and additional
key documents to increase uptake of the treatment.
Build and maintain partnerships with key stakeholders throughout
the organization, commercial vendors, payers, and providers.
Develop commercial relationships and distribution plans;support
vendor evaluation, selection, commercial drug inventory and
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.
Determine the supply chain and distribution options within the
REMS requirements. Work to find the most direct route of
distribution to certified clinics for onsite delivery of treatment
under direct observation.
Degree requirement minimum: Bachelors, advanced degree such as
MBA is preferred
10+ years of experience in the pharmaceutical industry with
exposure to the mental health field (PTSD)
Proven cross functional leader who has successfully overseen FDA
commercial launches of at least two pharmaceuticals or biotech
Strong project management skills and experience in handling
cross-functional initiatives across clinical, manufacturing, and
Experienced at problem analysis and developing solutions
Strong communication and diplomatic skills; ability to give
presentations to a wide spectrum of audiences
Ability and willingness to work "hands on and driven to achieve
Familiar with ICH-GCP and relevant FDA and international
regulations and guidelines