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Head of Commercialization and Patient Access

Company: The Ascent Services Group, Inc
Location: Santa Cruz
Posted on: September 12, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company

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 Plans.

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 assessment systems.

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 products

Strong project management skills and experience in handling cross-functional initiatives across clinical, manufacturing, and commercial organizations

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 goals

Familiar with ICH-GCP and relevant FDA and international regulations and guidelines

Keywords: The Ascent Services Group, Inc, Santa Cruz , Head of Commercialization and Patient Access, Other , Santa Cruz, California

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