At EnClear Therapies, we are thinking differently about neurodegenerative disease. Looking at new and novel ways to impact these complex diseases and deliver meaningful therapies as quickly as possible.

 

We believe that diversity fuels innovation. EnClear Therapies is committed to equal employment opportunities regardless of race, color, genetic information, creed, religion, sex, sexual orientation, gender identity, lawful alien status, national origin, age, marital status, or protected veteran status. We support an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance.

EnClear Careers

  • Principal, Regulatory Affairs

    Role and Responsibilities

    EnClear Therapies has developed a novel, first-in-class therapeutic platform for treating neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS). We are hiring a Principal, Regulatory Affairs to join our incredible team and lead regulatory strategy, program planning and execution, communications with FDA, and preparation of filings for the device as we move to first-in-human studies. Reporting to the Chief Medical Officer, this role will have a significant impact on the company’s plan to deliver a novel therapy to an underserved patient population. This position will work closely with the CMO, Heads of R&D and Biology, and the CEO as a key member of a team dedicated to improving healthcare for a unique population. 
     

    Responsible for:

    • Developing and managing the regulatory strategy for the EnClear System in collaboration with the Chief Medical Officer and key outside subject matter experts and consultants

    • Managing the delivery of all regulatory deliverables, including IDE, PMA, and 510(K) filings

    • Communicating with external regulators (FDA) and advisors, as well as key internal stakeholders

    • Partnering with the VP of R&D, Director of R&D, CMO, and Head of Biology to ensure alignment of the EnClear System and research strategies

     

    Qualifications and Education Requirements

    BS/MS/PhD in a scientific discipline; RAC certification a plus.

    • Minimum 5 years’ experience in regulatory discipline in medical devices, biotechnology, or pharmaceuticals

    • Experience as lead or first-line support on regulatory filings, including IDEs, PMAs, or 510(K)s.

    • Excellent understanding of regulatory guidelines, procedures, and communications etiquette with regulators 

    • Strong leadership, collaboration, communication, and organizational skills, with ability and desire to work as part of a team dedicated to innovation.

    Josh Vose, MD, MBA

  • Sr. Director, Business Development

    Role and Responsibilities

    EnClear is creating novel, first-in-class therapeutics for neurodegenerative disease and therapeutic delivery systems. This position reports the President and CEO, leading Business Development. The primary responsibility of the newly created position is to lead the development and execution of platform and product R&D collaborations with biotech and global Pharma/Device Corporations. This position will work closely with C-Suite in further financing the company through dilutive and non-dilutive means.

     

    This position will provide business-related guidance to inhouse and partnered programs in target and discovery across major therapeutic areas, and in key modalities. As well as a commercial voice to enterprise governance articulating clear marketplace realities, partner interests and patient-oriented imperatives to guide corporate strategy and R&D.

     

    • Provide business development expertise and design partnering structures tailored to the profile of each envisioned collaboration.

    • Provide outstanding transaction skills through the entire deal making process to secure and implement attractive deals.

    • Proactively monitor the external business environment and maintain a knowledge base of licensing transactions and other company activities.

    • Drive contribution from colleagues for scientific, legal, intellectual property, finance, communication, and commercial and lead term sheet and contract negotiations.

    • Promotes EnClear Therapies as the partner of choice at business partnering meetings and scientific conferences

    Qualifications and Education Requirements

    • 10+ years industry experience with at least 5+ years in Business Development, including lead role in deal execution

    • Keen understanding of assets covered in deals/alliances

    • Understanding of complex deal structures requiring coordination with finance, legal, tax, R&D and commercial stakeholders

    • Proven track record at sourcing, structuring, negotiating and closing different types of partnerships from discovery stage assets through commercialization stage

    • Demonstrated history of leading local, international, global, and cross-functional teams and strategic corporate initiatives

    • Established network of contacts in key academic institutions, biotechnology and pharmaceutical companies, VC community

    • Scientific expertise in Neurodegenerative disease, Oncology, Immuno-Oncology, Immunology, Biochemistry and related fields, including the drug development and therapeutic commercialization process.

    Anthony DePasqua

EnClear Therapies, Inc.
65 Parker Street #3A. Newburyport, MA 01950

Phone: 978-358-1557

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