General Counsel

About Prilenia

Prilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a VP/SVP, Clinical Development to join its team in East Coast US / Europe (preferably NL) or Israel.

We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.

Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases.

About the role

The General Counsel will be responsible for managing the legal function including outside legal advisors and counsel. The duties of this position include, but are not limited to, corporate affairs, commercial transactions and contracts, employment law, intellectual property, M&A, financing, regulatory and compliance matters, privacy, and other topics.

The General Counsel will also provide senior management with effective legal counsel on company strategies and their implementation and manage overall corporate legal risk.

The position will initially report to the COO.  

• Manage and direct general corporate legal matters, including corporate structure, compliance, transactions, intellectual property, employment law, regulatory matters, risk management, financing activities, and general contract management.
• Manage the overall legal workload including working closely with external counsels globally to draft, review, and negotiate a wide variety of agreements including material transfer, license, advisory board, market research, and other intellectual-property-related matters with domestic and international parties including partners, vendors and users ranging from global biotech companies to healthcare organizations, research and clinical sites, property owners, subcontractors, and government agencies.
• Manage legal aspects of the Company’s financing activities and corporate structure considerations, including assessing and supporting current and future business structures and legal entities.
• Provide legal and compliance support for the company's future commercialized product(s) - this includes overseeing and providing legal support on marketing and medical affairs strategies, promotional tactics and materials, advertising campaigns and programs, labeling, healthcare fraud and abuse laws, anti-kickback statute, and other laws impacting the commercialization, compliance, and reporting in the Europe, U.S. and Canada.
• Supervise outside counsel and related budgets and build a cadre of appropriate external legal support. Efficiently manage the company’s legal activities while minimizing risk for the business.
• Keep abreast of legislation, pharmaceutical, regulatory and policy initiatives to counsel business leaders and legal team on potential legal risks in a way that continues to advance corporate strategy while protecting corporate assets, integrity and reputation
• Ensure compliance with relevant regulations, corporate governance requirements, and other relevant legal and statutory requirements.
• Develop guidance to ensure an effective global ethics and compliance program. 

• JD (or equivalent) with 10+ years of general corporate legal or regulatory experience in biopharma industry with recent in-house GC/deputy-GC experience in biotech/pharma or a combination of both
• Understanding of the compliance and reporting requirements of a commercialized biopharmaceutical product
• Experience in public company (preferred: IPO experience)
• Experience working in biotech/pharma (or equivalent) through late stage and commercial (preferred: first launch experience)
• Well versed in EU and US healthcare laws and how to navigate the different legal requirements in the most effective and efficient way
• Ability to move easily between a hands‐on, operations‐focused view and a strategic outlook and manage multiple types of legal activities with various external counsels.
• Demonstrated experience in commercial legal analysis and planning, including effectively managing multiple projects/priorities with multiple external counsel support.
• Proven ability to make sound judgments and decisions. Ability to quickly assess problems/situations and provide effective resolution/solutions.
• Excellent people skills and ability to build and maintain positive work relationships to effectively interface at all levels across the organization.
• Pragmatic, flexible, high level of integrity, action and goal oriented.
• Ability to stay engaged and work effectively in a remote global work environment

Location/Time/Travel:

·        The position is full time remote position in the East Coast US / Europe (preference for the Netherlands) or Israel.

·        Flexible schedule with frequent calls across Israel, North America and Europe time zones

·        Some travel expected, including international