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Associate General Counsel

Cambridge, MA

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary:

Alkeus’ legal department seeks an Associate General Counsel reporting directly to the Company’s Chief Legal Officer. As a key partner and business strategist, this position will provide broad legal advice and support for all matters related to Alkeus’ lead compound, gildeuretinol acetate (ALK-001). Supported business teams including product sales and marketing, commercial operations, medical affairs, regulatory, and market access (patient access, contracting and distribution). This position is based at our Cambridge, MA headquarters. Only local candidates will be considered.

Primary Responsibilities:

  • Provide legal advice and counseling on a broad range of healthcare, commercial and general corporate topics in support of preparations for the launch of Alkeus’ lead product candidate, including but not limited to pre-approval activities, marketing strategies, promotional tactics and materials, advertising campaigns and programs, disease awareness activities, collaborating with/supporting patient advocacy groups, healthcare professional (HCP) engagements, advisory boards and interactions with others in a position to influence healthcare decisions (e.g., payers, distributors, etc.)
  • Advise clients on issues related to advertising and promotion of pharmaceutical products (including FDA regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, Sunshine Act, Food and Drug Cosmetic Act, etc.)
  • Own the contracting process including drafting and negotiating a variety of third party contracts, including service agreements with consultants and HCPs, CROs, clinical trial sites, specialty pharmacies and a variety of commercial vendors
  • Review and approve scientific, disease state and promotional campaigns; and provide guidance regarding promotional and non-promotional activities
  • Advise on matters related to reimbursement activities, access services, patient support and advocacy, and patient assistance programs
  • Review and approve grants, medical education program activities and charitable contributions
  • Address a broad array of general legal matters to support the company's business, working closely with the Chief Legal Officer and internal business clients across functions
  • Help develop, manage and implement Legal policies, templates and procedures
  • Oversee outside counsel where necessary

 

Skills and Qualifications:

 

  • Juris Doctor degree with exceptional academic credentials
  • 7+ years of relevant attorney experience, including training at a leading law firm, ideally in the life sciences practice, and time spent in-house, ideally at a leading biotech, pharmaceutical or life sciences company, in roles of increasing responsibility
  • Must be admitted, active and in good standing with the Massachusetts Bar, or with another state bar and registered, or eligible to register, as in-house counsel in Massachusetts
  • Prior drug launch experience for innovative first and/or best in class therapies, preferably in the rare disease space
  • Strong negotiation, drafting and analytical skills
  • Demonstrated excellent communication (oral and written), teamwork, presentation, training, organizational, interpersonal, and problem-solving skills
  • Ability to simultaneously manage multiple client demands and shifting priorities within a fast-paced, high-intensity and dynamic environment
  • Exceptional verbal and written communication skills coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision
  • Demonstrated ability to make decisions in areas where a high degree of professional judgment is required
  • Ability to effectively work with and manage several vendors and law firms supporting the Company’s legal efforts
  • Ability to work in person in Alkeus’ Cambridge, MA headquarters

 

Skills and Key Success Factors:

  • Entrepreneurship spirit with a passion to build, learn and evolve with the team
  • Highly organized and detail oriented with a passion to deliver quality results
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values, and ethical standards
  • Ability and aptitude to manage ambiguity and adaptability to change
  • Emphasize the need for self-motivation and the ability to work independently

 

Other Relevant Information:

Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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