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Associate General Counsel - Legal Affairs

Associate General Counsel - Legal Affairs

ID 
2018-1214
Category 
Legal
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

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 is responsible for providing legal counsel to a broad range of internal clients on issues related to risk mitigation, legal and regulatory considerations in the conduct of clinical trials, public disclosure documents, and for developing 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 serve as the primary legal advisor to the Commercialization and New Product Planning functions, provide timely and balanced counsel to a variety of other functions, and work directly with the General Counsel in the development and maturation of the company compliance program. In addition, the ideal candidate will be a highly capable and interested “legal athlete” with the ability to advise and assist the General Counsel with a wide variety of business and legal matters in addition to the core areas identified.

 

Responsibilities:

  • Provides effective legal support for matters regarding the research, development and future commercialization of products and product candidates and ensure that current decisions are not in conflict with long-term goals.
  • Provides advice, guidance and counsel to the commercialization and new product planning functions, as well as to the General Counsel, on commercialization strategies, programs, policies, practices and initiatives in compliance with all healthcare laws, guidance documents or opinions, and industry codes. Provides legal feedback and direction on scientific, corporate or other materials proposed for publication or other external disclosure. Assists with the development of review processes for a variety of potential business activities, including but not limited to, promotional review committees or similar.  
  • Reviews and provides legal guidance concerning, and trains employees on interactions with, health care professionals, patients and others who may be in a position to influence health care decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations and standards.
  • Supports and advises the General Counsel on the design and execution of a robust healthcare compliance program, including compliance policies and procedures, fair market value methodologies and risk assessments. Collaborates with all departments to develop plans to improve compliance and governance infrastructure.
  • 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, data privacy and security issues and on complex business issues, compliance matters or risk assessments. Makes recommendations for best approaches considering risks and long-term consequences.
  • Drafts, reviews, revises and negotiates a variety of agreements for the Company and advises on interpretation of existing agreements.
  • Reviews and assists with the preparation of responses to communications from regulatory authorities.
  • Provides counsel and support when necessary to any internal investigations, contract disputes, or other legal matters. Supports any litigation that arises.
  • 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.

Qualifications

Education & Other Credentials

  •  Juris Doctorate from an ABA-accredited law school.
  • License to practice as an attorney in at least one US jurisdiction.

 

Experience

  • At least 10 years of relevant experience
  • Experience working in the legal department of a commercial-stage pharma/biotech company
  • Experience providing legal counsel on new product commercialization activities
  • Significant knowledge and expertise of either FDA or health care legal (fraud and abuse and market access) considerations relevant to the biopharmaceutical industry

 

Knowledge, Skills and Abilities

  • Familiarity with corporate compliance programs; comprehensive understanding of legal terms, and excellent negotiation skills.
  • 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.
  • Proven ability to develop and implement legal strategies that support business and financial objectives.
  • Strong attention to detail.
  • Excellent communication skills (verbal and written).
  • 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.
  • Strong interpersonal skills with ability to effectively communicate with all levels of personnel.
  • High energy level and high degree of self-motivation, with a sense of urgency to achieve stated business goals.
  • Demonstrate 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.
  • Sound judgment and commitment to ethical conduct.
  • 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.

 

Supervisory Responsibilities

No

Preferred Qualifications

  • A combination of both in-house experience in a biotechnology company and law firm practice
  • Degree in a scientific discipline

Statement

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 info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.