MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Associate General Counsel will be a key partner to the General Counsel in support of continued corporate growth, including advising on compliance, corporate governance, commercial contracting, and legal operations. The position will provide legal advice to a broad range of internal clients related to legal and regulatory considerations in the development and commercialization of biopharmaceutical products and the development of compliance strategies, infrastructure and training. Will translate legal requirements into succinct and meaningful operational principles to advance the mission and business objectives. The position will provide timely and balanced counsel to the enterprise and specific departments on a variety of legal issues, including government pricing and reimbursement, market access, litigation and disputes, and general contracts as needed. The Associate General Counsel will work directly with the General Counsel in the development and maturation of the company compliance program.
Responsible for, in collaboration with the General Counsel /Corporate Compliance Officer, the execution, maintenance and continuous improvement of a robust healthcare compliance program, including drafting or revising compliance policies and procedures, and designing and conducting training, monitoring and auditing. Collaborates with all departments to implement, evaluate and improve the effectiveness of corporate compliance and governance infrastructure.
Supports and advises the General Counsel on Board and corporate governance related matters, including preparation of Board materials and annual and periodic corporate documents and filings, maintenance of corporate records, and advising on legal requirements and best practices.
Serve as the lead attorney on market access matters, including legal support for the interacting and/or contracting with wholesalers, distributors, group purchasing organizations, integrated delivery networks commercial, state and federal payers, and managed care organizations.
Provide guidance to company regarding developments in federal and state laws and relevant litigation relating to price reporting and relevant contracting and develop appropriate company policies and processes.
Provide guidance and work collaboratively with internal business clients to ensure compliance with statutory and regulatory drug price reporting obligations.
Provides effective legal support for matters regarding the research, development and commercialization of products and product candidates and ensure that current decisions are not in conflict with long-term goals.
Assists with the oversight or development of review processes for a variety of potential business activities, including but not limited to, promotional review committees, publication committees or similar.
Defines risks and clearly communicates and explains those risks to appropriate internal decision-makers for discussion and resolution.
Coordinates with senior leadership for each operational group with respect to legal support to meet corporate priorities. Interacts with various internal clients and functional groups to effectively address legal and business questions and provide guidance as well as practical solutions.
Supports administrative law activities as needed, such as reviews of government agency actions or requests for agency interpretation of regulatory enforcement issues.
Advises internal clients on contract interpretation, dispute resolution matters, and on complex business issues, compliance matters or risk assessments. Makes recommendations for best approaches considering risks and long-term consequences.
Provides counsel and support, when necessary, to litigation matters, any internal investigations, contract disputes, or other legal matters.
Reviews and assists with the preparation of responses to communications from regulatory authorities.
Oversees the legal contracting management function including working with contract management system and personnel, and collaborating to ensure and implement a forward thinking approach to contract management.
Provides additional support to the General Counsel on other matters and assume other responsibilities, as assigned, including but not limited to the preparation and review of regular or recurring securities filings.
Education & Other Credentials
Juris Doctorate from an ABA-accredited law school
License to practice as an attorney in at least one US jurisdiction.
At least 12 years of relevant experience
Experience working in the legal department of a commercial-stage biotech company
Experience providing legal counsel on corporate compliance, market access, new product commercialization activities
Experience designing and implementing policies and processes pertaining to pharmaceutical regulations
Experience managing cross-functional legal teams
Prior experience supervising other lawyers
Experience and expertise in negotiating and drafting complex agreements
In-house experience providing risk assessments and legal counsel regarding financial interactions with health care professionals, scientific or product communications with health care professionals or payors, and healthcare compliance.
Knowledge, Competencies and Abilities
Sound business and legal judgment, and strategic and analytical thinking, and a forward-thinking approach to legal department operations
Significant knowledge and expertise of either FDA or health care legal (fraud and abuse and market access) considerations relevant to the biopharmaceutical industry
Strong knowledge and understanding of all healthcare laws, guidance documents or opinions, and industry codes relating to the discovery, development and commercialization of biopharmaceutical products, including but not limited to FDCA, FDA guidance Documents, Fraud and Abuse laws, Anti-kickback Statute, federal and state transparency laws, and OIG Advisory Opinions, etc.
Understanding of pharmaceutical regulatory and compliance environment and working knowledge of general corporate matters
Demonstrates an enterprise mindset and an ability to interact with and influence all levels of the organization
Outstanding interpersonal, written and oral communication skills
Complex project management skills, including the ability to multi-task across high-volume projects, prioritize and manage timelines effectively in a responsive and professional manner
Familiarity with corporate compliance programs; comprehensive understanding of legal terms, and excellent negotiation skills
Proven ability to develop and implement legal strategies that support business and financial objectives.
Strong attention to detail
Ability to apply legal concepts and practical judgment to dynamic business needs
Must be able to manage conflicting priorities in fast-paced environment and work independently on a wide range of issues and projects, while delivering high-quality work under a tight timeline
High energy level and high degree of self-motivation, with a sense of urgency to achieve stated business goals
Demonstrates ability to think creatively and devise solutions to challenging problems
Ability to mentor legal staff in areas of expertise
Ability to manage and serve a wide range of client groups within the company by recognizing and responding pragmatically to urgent situations and demanding clients
Possesses sound judgment and commitment to ethical conduct
A combination of both in-house experience in a biotechnology company and law firm practice
Experience in a Compliance department
Corporate, M&A and/or public company experience
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer/Veterans/Disabled
We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.