This position will provide strategic legal counsel to a broad array of legal matters, particularly research, vendor and collaboration arrangements, facing Alkermes' Research & Development, Medical Affairs and Clinical Development divisions. The attorney will provide client counseling; drafting, reviewing and negotiating life sciences agreements of relative complexity; and otherwise assisting with the needs of the company. The attorney must possess working knowledge of laws, regulations and standards relevant to the biotech/pharmaceutical industry (e.g., FDA regulations, fraud and abuse laws, federal sunshine act, GxP regulations, privacy laws, etc.). This position is located in our offices in Waltham, Massachusetts.
Provide full-service strategic legal advice (with limited oversight or guidance from managing attorney) to internal client functions, each as necessary to support the needs of the business.
Evaluate and participate in cross-functional discussions and engage with client functional leadership about potential contractual arrangements, and draft and negotiate a high-volume of specialized agreements necessary for the day-to-day operations of a life sciences company. Provide legal advice, counsel and strategic input to clients regarding these arrangements, including with regard to emerging legal and regulatory issues, risk mitigation or management.These agreements include confidentiality/non-disclosure agreements; biologics vendor service agreements; license agreements; consultant service agreements; material/technology transfer agreements; supply agreements; expanded access/compassionate use agreements; investigator-sponsored study agreements; clinical trial agreements (and associated documents); collaboration agreements and other development-related agreements.
Counsel clients on the legal implications of research and development initiatives, particularly external research collaborations (academic and/or company).
Develop, implement and communicate contracting best practices, standards and timelines to internal clients.
Develop initiatives to strengthen the Legal Department and business operations through systems improvements, and the preparation, implementation and refinement of forms, processes and procedures.
Develop and maintain expertise in laws (current and new), regulations and industry trends affecting the company.
Generate reports, presentations, memos and other documents for the Legal Department, internal clients and/or business leaders.
- Support other in-house attorneys or projects as needed.
- J.D. degree from an accredited law school with the license to practice law in the United States.
- Minimum of 5 years of experience with a life sciences company, or a law firm or an academic medical center, counseling clients on the negotiation and drafting of agreements.
- Ability to draft concise and effective contractual documents.
- Excellent cross-disciplinary oral and written communication skills with an ability to adapt style to communicate at all levels within the organization.
- Familiarity with intellectual property issues and drafting contractual intellectual property provisions within agreements.
- Ability to work independently on complex projects as well as collaboratively with team members as needed.
- Proven track record of building relationships with cross-functional stakeholders -- internal and external.
- Eagerness to creatively engage the Legal Department, internal clients and/or business leaders to fully understand complex issues and articulate creative and practical solutions and alternatives.
- Self-motivated and able to adapt quickly to gain trust and credibility from team members.
Ability to manage multiple priorities simultaneously and respond to rapidly shifting priorities in ambiguous or challenging situations.
- Flexibility and willingness to work on a broad variety of matters and provide substantive support for the company on an as-needed basis.
Familiarity with drafting, negotiating and managing agreements with international vendors (experience with China and India a strong plus).
- Negotiating experience with hospitals, teaching institutions and universities.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.