Director, Compliance Counsel (Healthcare Law Compliance)

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the healthspan of people with cardiovascular and neuromuscular diseases of impaired muscle function.

We are seeking a Compliance Counsel to join our Compliance group.  This position will have the opportunity to provide compliance and business conduct advice and support across the company, although based on experience and prior job responsibilities, this role will also have primary responsibility for defined functional areas.  This position will report to the VP, Chief Compliance Officer.

Responsibilities

• Serve as a key subject matter expert in supporting the business conduct and compliance advisory needs of the Commercial organization.
• Expert understanding of the laws, regulations, industry standards, and guidelines for interactions with healthcare professionals and other Ethical codes and regulations.
• Advise and counsel on appropriate business conduct interactions with healthcare providers, patients, managed care entities, academic institutions, and government entities, including on topics such as fair market value, advisory board participation, sales and marketing, .
• Enhance and implement systems or capture mechanisms for all business conduct and compliance advisory guidance for company posterity (e.g, electronic resource directory).
• Oversee and manage the process and capture of timely, accurate and consistent data for incorporation into filings and reports related to required HCP payment disclosure, including U.S. Sunshine Act and state law reporting.
• Partner with all Company internal clients to clarify and help validate data, and prepare reports and filings for transparency data for final attestation by the Chief Compliance Officer.
• Oversee, manage, and engage in continuous improvement, review, drafting, and project management for all Compliance-specific policies, SOPs, guidelines, and work instructions.
• Serve as an accountability partner for managing, maintaining, documenting, and dispatch of all Compliance-training materials, policies, or content (including New Hire Compliance Trainings) and other LMS project management areas.
• Oversee and manage the process, data capture, analytics, and report generation for compliance monitoring activities (live monitoring and process/documentation monitoring) in conjunction with the Chief Compliance Officer.
• Serve as principal Compliance reviewer for the Corporate Affairs Grants Review Committee (GRC).
• Serve as primary reviewer for key compliance and risk identification expertise in both the Promotional Materials Review Committee (PMRC) and the Medical Review Committee (MRC).
• Assist and partner with the Chief Compliance Officer on various privacy-related projects and policies, and Privacy project management areas, including the Privacy Council and affiliated workgroups, as applicable (e.g, Artificial Intelligence or Cybersecurity)
• Partner and collaborate, as appropriate and applicable, with Legal colleagues on matters that pertain to overlap of compliance and Legal (e.g., Privacy documentation reviews)
• Keep apprised of applicable federal, state, and local laws and regulations and apply them to areas of responsibility.
• Experience with drug advertising and pharmaceutical drug promotion practices, and privacy (CCPA and GDPR) helpful.

Qualifications

• JD degree with a minimum of 5-10 years of experience as in-house counsel or associate at a major law firm with a background in biotechnology, pharma or healthcare related matters. A combination of both in-house and law firm experience is a plus. However, expertise in healthcare law compliance is a requirement.
• Admitted to at least one state bar. Admitted to California bar or admitted as Registered In-House Counsel required.
• Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility.
• Solution-oriented and growth