General Counsel

Alkermes, Inc.
Waltham, MA Full Time
POSTED ON 7/25/2023 CLOSED ON 11/5/2023

What are the responsibilities and job description for the General Counsel position at Alkermes, Inc.?

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

On Nov. 2, 2022, Alkermes plc announced its intention to explore separation of its oncology assets, including nemvaleukin alfa, IL-12 and IL-18. Alkermes plc intends to create a new, publicly-traded company to develop and commercialize such oncology assets. Referred to herein as "OncologyCo." Alkermes, Inc., a subsidiary of Alkermes plc, is recruiting the position of General Counsel for OncologyCo. in advance of its establishment as a publicly-traded company on The Nasdaq Stock Market.

Primary job responsibilities include:

  • Manage the company's corporate legal matters, including corporate governance, securities matters, intellectual property, business development activities including licensing and acquisitions, and other matters such as employment, litigation, finance/banking, regulatory, compliance, commercial, and privacy.
  • Efficiently guide the company's legal activities and minimize risks for the business, including development of functional plans for managing legal matters, which may include activities to be performed in-house or through third-party counsel or other providers.
  • Provide high quality, timely and practical legal advice and guidance, to identify and help resolve critical legal and business issues arising from, among others, regulatory, pre-clinical, clinical, technical operations, and research and development activities.
  • Advise the CEO and senior management on strategic and complex business issues including deal structuring, licensing, intellectual property, risk management and employment law.
  • Lead the company's compliance efforts with applicable reporting requirements of the U.S. Securities and Exchange Commission and Nasdaq, including responsibility for securities law and Section 16 filings, management of an insider trading policy/preclearance program and other equity-related matters and advising on disclosure issues and related policies and procedures.
  • Review and approve presentations, press releases, website materials, brochures, media (including social media), and other company communications (internal and external).
  • Lead efforts on public or private debt, equity or other financings.
  • Serve as the company's Corporate Secretary and work with the Board and its committees to advise on matters of corporate governance and other matters of relevance to the Board and its committees.
  • Work with Irish counsel to ensure compliance with applicable Irish law and other laws or regulations applicable to Irish entities.
  • Ensure that the company has developed an effective global ethics and compliance program designed to prevent and detect violations of laws, company policies, or other misconduct; promote ethical practices; and ensure the implementation of the compliance program throughout the organization.
  • Shape and be responsible for intellectual property strategy and manage all the company's patent prosecution, enforcement and defense, including management of external patent counsel.
  • Advise on regulatory requirements regarding investigational product submissions, clinical trials, drug safety management and, if and as applicable, commercialization in the United States and other key jurisdictions.
  • Structure and negotiate business agreements, including engagement letters, confidentiality agreements, term sheets, merger/acquisition agreements, license agreements, R&D agreements, supply, manufacturing and distribution agreements, government contracts, real estate contracts, joint ventures and strategic alliances.
  • Represent OncologyCo. in interactions with regulatory authorities and governmental and non-governmental agencies, as appropriate, that may affect the company's development and commercialization plans.
  • Oversee and manage the legal aspects of internal cross-functional teams, such as development program teams or medical and legal review teams.
  • Manage and oversee the contracting process, working with internal and external counsel in drafting and negotiating all contracts, including master services agreements, clinical trial agreements, supply agreements, and material transfer agreements.

Qualifications

  • 15 years' experience in the biopharma/life sciences department or corporate department of a leading law firm and/or in-house legal department.
  • Experience in oncology is highly preferred.
  • JD from accredited law school and a license to practice law.
  • Experience drafting complex agreements, including licensing and collaboration agreements
  • Knowledge of and experience with the federal and state securities laws, corporate securities and stock exchange procedures
  • Ability to work independently on complex projects
  • Demonstrated ability to recognize and weigh business and legal risks, lead strategically and advance innovative solutions
  • Strong business and legal acumen, with the ability to identify and diagnose legal problems and articulate creative and practical solutions and alternatives
  • Ability to draft concise and effective contractual documents
  • Ability to interface with outside counsel, vendors, collaborators, all internal departments and all levels of management
  • Familiarity with intellectual property considerations preferred

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

#LI-AB1


Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

 

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