Description:

Summary:
Reporting to the Director of Compliance, the Associate Director/ Director-Product Counsel serves as the lead product counsel for Ionis marketed products and products in development. This is a dynamic position supporting multiple client groups, including teams within Ionis' Marketing, Patient Services, Market Access, Medical Affairs, and Commercial functions, providing advice on matters related to promotional and educational activities, engagements with healthcare providers and entities, and other applications of healthcare and regulatory compliance in the biopharmaceutical industry.

The Product Counsel also will have a dotted line to the Associate General Counsel for Research & Development. The Product Counsel is responsible for reviewing, drafting and advising on a variety of contracts and documents supporting Ionis' clinical research and development. Also, this position will be responsible for advising internal clients on a broad range of clinical research and development and contractual matters, and representing Ionis in negotiations and with external parties on research and development matters.

The Product Counsel provides legal support and advises business stakeholders in all levels of the organization, including senior management, as well as leads and/or plays a significant role in special projects and on cross-functional teams dealing with complicated legal and compliance issues. Such issues include the interaction of regulatory requirements, good clinical practices, and drug development requirements.

This role will also have significant interaction with Regulatory Affairs, Clinical Development, IT and other functions throughout Ionis. This position requires a problem-solving mindset, a high degree of collaboration with internal clients and colleagues, and the ability to exercise mature and reliable judgment in the company's fast-paced environment.

The preferred work locations for this role are in order: Carlsbad, CA (HQ office) or Boston, MA (office) or open to remote.

Responsibilities:
Compliance:
  • Provides advice, guidance and counsel to commercial, medical and corporate teams on sales and marketing strategies, programs, policies, practices and initiatives with respect to compliance with relevant U.S. healthcare laws, guidance documents or opinions, and industry codes (FDCA, FDA guidance, fraud and abuse laws, anti-kickback statutes, federal and state transparency laws, OIG Advisory Opinions, PhRMA Code, etc.).
  • Serves as the legal representative on cross-functional Promotional Review/Medical Review Committees to provide legal feedback and direction on advertising, promotional and educational materials submitted for review.
  • Supports medical and commercial development for assigned products, including regulatory and medical strategies, product safety, product liability analyses and risk-mitigation activities and label development.
  • Serves as the legal representative on cross-functional Medical Review Committee to provide legal feedback and direction on medical affairs materials and activities.
  • Reviews and provides legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations.
  • Supports execution of a robust healthcare compliance program, including creation and enforcement of company policies and procedures, risk assessments and ongoing monitoring.
  • Provides legal and compliance training to Ionis personnel and external consultants, including large group public speaking.
  • Proactively identifies risks, opportunities, and mitigating actions, and collaborates across business functions.
  • Partners with the Chief Compliance Officer and Compliance team to implement an effective ethics and compliance program.
  • Stays informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed.
  • Engages and efficiently manages external counsel as appropriate.

Legal:
  • Reviews and drafts clinical study agreements and ancillary documents supporting clinical research.
  • Advises stakeholders on informed consent, GDPR, and other privacy-related issues affecting clinical research.
  • Serves as the legal representative on clinical drug development teams to provide legal feedback and direction on clinical development projects.
  • Supports clinical development for assigned products, including preparation of clinical development documents and agreements, product safety support, research liability analyses and risk-mitigation activities.
  • Represents clinical development team in negotiations with vendors, clinical sites, and partners.
  • Provides legal and compliance training to Ionis personnel and external consultants, including large group public speaking.
  • Proactively identifies risks, opportunities, and mitigating actions, and collaborates across business functions to implement goals of clinical research stakeholders.
  • Stays informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed.
  • Engages and efficiently manages external counsel as appropriate.

Requirements:
  • Strong sense of integrity, business transaction transparency and the ability to balance business interests with the need to exercise independent judgment.
  • Proven capacity to cultivate strong client relationships and successfully influence leadership in a dynamic, innovative business climate.
  • Juris Doctorate or equivalent law degree required.
  • Admitted to state bar, CA or NY State Bar preferred.
  • Minimum of 5 years of professional work experience at a law firm or in-house legal department.
  • Minimum of 3 years in support of the pharmaceutical or biotech industry, whether as in-house counsel (pharma/biotech preferred) or in a law firm, including experience in regulatory law and commercial-related matters.
  • A thorough understanding of regulatory and legal frameworks governing the sales and marketing of approved medicines, and development of investigational medicines.
  • Demonstrated ability to grasp statutory and regulatory concepts quickly, and proactively identify and analyze potential legal issues and provide thoughtful and creative business-focused legal advice and solutions.
  • Experience conducting legal review of materials submitted for Medical/Regulatory/Legal (MLR) Review.
  • Knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry including FDCA, FDA guidance, privacy regulations (e.g., HIPAA, GDPR), fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines and state marketing compliance laws.
  • Knowledge and experience with managed markets, payer and PBM contracting, patient support programs and/or government pricing a plus.
  • Ability to work independently and in a fast-paced environment and handle multiple complex and confidential tasks.
  • Ability to analyze and interpret technical procedures, government regulations and legal documents.
  • Excellent communication and interpersonal skills.
  • Exceptional attention to detail and deadlines.