Executive Director, US Healthcare Compliance

Cytokinetics•South San Francisco, CA

4d•$337,500 - $393,800•Hybrid

About The Position

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.

Requirements

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.
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.
Proven success chairing high-level committees and influencing executive-level stakeholders in a fast-paced, matrixed environment.

Nice To Haves

Relevant graduate education, either a Juris Doctorate (JD) or other advanced degree is strongly preferred.

Responsibilities

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.
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-notch live and on-line training, and a robust, dynamic, data-driven monitoring program.
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.
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.