Vice President, Compliance

Ionis•Carlsbad, CA

2d•Remote

About The Position

The Vice President, Compliance is the senior leader responsible for the strategy, execution, and effectiveness of Ionis’ corporate compliance program. Reporting to the Senior Vice President, Chief Compliance & Quality Assurance Officer, the Vice President, Compliance directly manages Compliance Counsel and compliance professionals and sets the function’s priorities, operating plan, resources, and talent agenda within delegated authority. As Ionis expands commercialization and prepares for future product launches, this leader will build and maintain a risk-based, appropriately scaled compliance infrastructure; oversee governance, compliance risk assessment, and investigations; and provide clear recommendations and escalation to executive leadership and relevant governance committees. The Vice President, Compliance will help play a critical role fostering a culture in which employees raise concerns early, leaders act with integrity, and Compliance is a trusted, pragmatic partner to the business. Success in this role requires strategic judgment, executive presence, programmatic expertise, and the ability to influence across a complex matrix while developing a high-performing Compliance organization.

Requirements

Juris Doctor (J.D.) degree from accredited United States law school required.
Minimum of 15 years of relevant healthcare compliance experience in the biotechnology, pharmaceutical, medical device, and/or life sciences industry, with demonstrated experience designing, implementing, and enhancing comprehensive compliance programs.
Demonstrated commitment to ethics, integrity, values-based leadership, and the highest standards of quality.
Deep knowledge of U.S. healthcare compliance laws, regulations, guidance, and industry best practices, including requirements relating to product advertising and promotion, healthcare professional interactions, grants and sponsorships, transparency reporting, training, investigations, and policy development.
Proven ability to serve as a strategic advisor within a complex, matrixed organization; influence and engage stakeholders at all levels, including executive leadership; and provide pragmatic advice while navigating ambiguity.
Excellent leadership, project management, analytical, and problem-solving skills, with the ability to manage multiple priorities simultaneously and consistently deliver high-quality results in a fast-paced and rapidly evolving environment.
Exceptional oral, written, and presentation skills, with professionalism, judgment, and discretion to handle highly confidential and sensitive matters.
A resilient, adaptable, hands-on leader who is willing to engage at all levels of activity within a growing and dynamic company environment.
A positive, respectful, inclusive, and collaborative individual who fosters trust, encourages others, and strengthens organizational agility.
Excited by Ionis’ patient-centric mission to improve the lives of patients living with serious diseases.
Ability to travel approximately 15–20% of the time.

Nice To Haves

Experience supporting one or more U.S. biopharmaceutical product launches and/or commercial-stage operations preferred.

Responsibilities

Lead the Company’s Executive Compliance Committee and substantively support the Commercial Operations and Compliance Oversight Committee of the Board of Directors in its operations.
Serve as a key subject matter expert and strategic advisor on healthcare compliance matters, overseeing the development and ongoing enhancement of compliance policies, procedures, business practices, and guidelines that reflect applicable laws, regulations, guidance, codes, and industry standards.
Partner with executive leadership, the Chief Compliance Officer, the Chief Legal Officer, and the Commercial Operations and Compliance Oversight Committee to establish and reinforce a strong tone from the top and embed ethical conduct into leadership communications, business operations, strategic initiatives, and organizational culture.
Actively engage with Commercial, Medical, Clinical, Regulatory, and other business partners to provide proactive, practical compliance guidance on strategic and tactical initiatives, including product launch and commercialization activities.
Drive the implementation, maintenance, and continuous improvement of a robust and effective healthcare compliance program that is aligned to Ionis’ corporate strategy, commercialization plans, and risk profile.
Oversee and conduct compliance investigations into allegations of violations of applicable laws, regulations, or Company policies, and ensure appropriate corrective and preventive actions are implemented.
Oversee Compliance representation on Ionis’ promotional and medical review committees, assuring consistent advice and guidance, as applicable.
Advise on key areas of engagement with healthcare professionals, including grants and sponsorships, donations, advisory boards, speaker programs, third-party due diligence, and other key risk areas.
Manage, coach, and develop Compliance Counsel and compliance professionals, including setting clear expectations, providing timely feedback, conducting performance reviews, and addressing performance issues.
Conduct ongoing compliance risk assessments and regularly evaluate ethics and compliance issues, trends, regulatory developments, and the effectiveness of the Company’s compliance culture; recommend enhancements based on business needs, emerging risks, and regulatory expectations.
Foster a safe and open environment in which employees feel comfortable speaking up and raising concerns, and in which Compliance is viewed as a trusted strategic partner.
Collaborate with Compliance Operations on the compliance training and communications strategy, translating legal and regulatory requirements into engaging, practical, and business-relevant guidance.
Develop and manage the functional budget and workforce plan, including headcount, external counsel, vendors, technology, and other resources required to deliver the Compliance program effectively.
Support other responsibilities in service of the Compliance team, functional, and/or corporate strategies and goals.