Executive Director, US Healthcare Compliance

Cytokinetics; San Francisco (CA); On-site; USD 338,000 - 394,000; Full time

Benefits offered by this job

Stock options

Health insurance

401k retirement benefits

Wellness stipends

Job summary

Cytokinetics seeks an Executive Director, U.S. Healthcare Compliance to lead a small team and architect the U.S. compliance framework as part of the MYQORZO program launch.

You will develop clear policies, drive top-line training, and implement a data-driven monitoring program, while serving as Chair of the Global Healthcare Compliance Committee. You will influence senior stakeholders, ensure alignment with OIG and PhRMA guidelines, and work closely with legal, finance, and operations to

Qualifications

• 15+ years of compliance experience in the U.S. either in-house or at a law firm serving biopharmaceutical clients.
• Strong command of U.S. federal and state pharmaceutical laws and codes.
• Proven ability to lead senior-level committees and influence executives.
• Experience chairing cross-functional compliance initiatives.

Responsibilities

• Lead US Healthcare Compliance program aligned with industry guidance.
• Architect and oversee policies, training, and data-driven monitoring.
• Direct brand compliance for product lifecycle and medical affairs activities.
• Chair the Global Healthcare Compliance Committee and report risks to executives and Board.

Skills

Leadership

Regulatory expertise

Stakeholder management

Compliance program development

Education

Juris Doctorate (JD) or advanced degree

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

As Cytokinetics advances its mission to improve the lives of people with cardiovascular diseases, we are seeking a strategic leader for the role of Executive Director, U.S. Healthcare Compliance.

In support of our launch of MYQORZO® (aficamten), you will lead a small team of compliance professionals as the primary architect of our U.S. compliance framework. You will ensure that as we scale our commercial and medical affairs operations and patient support programs, we maintain an uncompromising commitment to ethical interactions. This role also serves as the Chair of the Global Healthcare Compliance Committee under our risk and compliance oversight framework.

Responsibilities

• Cytokinetics' Culture of Corporate Compliance: Building on a strong foundation, working with the company's senior leadership to further strengthen and nurture all components of Cytokinetics' culture of business integrity and compliance.
• US Healthcare Compliance Program: Drive Cytokinetics' U.S. compliance program consistent with OIG Compliance Program Guidance for Pharmaceutical Manufacturers. Working collaboratively with legal, finance, and operational colleagues, you will play an instrumental role in the development, maintenance, and continuous improvement of that program, emphasizing clear and accessible policies to govern behaviors, top-on-line training, and a robust, dynamic, data-driven monitoring program.
• Launch and Cardiovascular Compliance: Lead the brand compliance strategy for the MYQORZO® commercial lifecycle, constructing effective compliance operations enabling product promotion, unbranded programs focused on cardiovascular health, medical affairs activities, and market access specific to commercialization of the MYQORZO brand.
• Global Committee Chair: Chair the Global Healthcare Compliance Committee, leading the cross-functional oversight of interactions with HCPs and HCOs. You will be responsible for identifying, managing, and reporting global operational risks to the company's executive management team and to the Board of Directors.

Qualifications

• Experience: 15+ years serving as a compliance professional in the United States, either in-house at a biopharmaceutical company, at a major law firm serving biopharmaceutical clients or both.
• Relevant graduate education, either a Juris Doctorate (JD) or other advanced degree is strongly preferred.
• Subject Matter Expertise: Deep familiarity with US federal and state laws and regulations and self-regulatory codes and guidelines applicable to the development and commercialization of pharmaceutical products, including the Anti-Kickback Statute, False Claims Act, Physician Payment Sunshine Act and the PhRMA Code.
• Leadership: Proven success chairing high-level committees and influencing executive-level stakeholders in a fast-paced, matrixed environment.

Pay Range

The expected salary range for this position based on the primary location of South San Francisco, CA is $337,500-$393,800. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Cytokinetics is an Equal Opportunity Employer