Senior Manager, Healthcare Compliance
Cytokinetics
Summary
Cytokinetics is seeking a Senior Manager of Healthcare Compliance to join our Compliance organization. This position will play a critical role in ensuring the effectiveness of Cytokinetics' healthcare compliance program. You'll enhance, implement, and maintain a risk-based compliance monitoring and oversight framework, working across Compliance, Legal, and Internal Audit teams globally. Your work will drive continuous improvement, support legal and regulatory requirements, and serve an essential part of the 7 Elements of Effective Compliance Programs for Pharmaceutical Manufacturers. You will also support policy and procedure development, training and compliance program administration. This position will report to the Director, Healthcare Compliance. This is an in-office role only based either in our South San Francisco, CA or Radnor, PA office with expectation for regular work travel up to 25%.
Job description
Responsibilities
- Expert understanding of the laws, regulations, industry standards, and guidelines for interactions with healthcare professionals and other Ethical codes and regulations
- Develop, implement, and maintain a risk-based compliance monitoring and oversight program across Compliance, Legal, and Internal Audit teams
- Travel nationwide to participate in live monitoring of field activities, including field rides, speaker programs, advisory boards, congresses, and symposia
- Coach and provide compliance guidance to Field-based personnel
- Manage the design and execution of compliance monitoring activities, including thematic reviews, continuous monitoring, and targeted desktop assessments across various business functions to assess adherence to corporate policies, regulations, and industry standards.
- Design and implement a compliance Monitoring and Oversight framework, ensuring alignment with regulatory expectations and internal policies
- Develop, assign, coordinate, and track compliance-related training for employees across functions. Identify training gaps and create targeted training content to address knowledge needs
- Serve as an accountability partner for managing, maintaining, documenting, and dispatch of all Compliance-training materials, policies, or content
- Prepare summaries and reports of monitoring results, compliance activities, risk assessments, and training outcomes, maintaining compliance documentation in an organized manner
- Partner with all Company internal clients to clarify and help validate data and prepare reports and filings for transparency "Sunshine Act" 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
- Support issue management processes and promote a strong culture of compliance across the organization
- Partner and collaborate, as appropriate and applicable, with Legal colleagues
- Keep apprised of applicable federal, state, and local laws, industry codes and regulations and apply them to areas of responsibility
Qualifications
- Demonstrated expertise in pharmaceutical / life science & health law compliance is required.
- Minimum of 6+ years of experience in biotechnology, pharmaceutical, or life science related matters.
- Bachelor's degree in Finance, Business, Law, Compliance, or a related field.
- Demonstrated experience conducting field monitoring for a commercial health science organization
- Ability to travel (estimated 25% within a year).
- Experience with training and/or monitoring and analytics in the bio/pharma industry preferred.
- In-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry preferred.
- Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility.
- Excellent communication skills, both oral and written.
- Excellent analytical skills, with a strong ability to draft and review documents, analyze and provide compliance guidance, and apply policy guidance to business needs.
- Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper ethical and compliance standards.
- Team-oriented, sound judgment, self-motivation and willingness to take initiative.
Requirements
- Demonstrated expertise in pharmaceutical / life science & health law compliance is required.
- Minimum of 6+ years of experience in biotechnology, pharmaceutical, or life science related matters.
- Bachelor's degree in Finance, Business, Law, Compliance, or a related field.
- Demonstrated experience conducting field monitoring for a commercial health science organization
- Ability to travel (estimated 25% within a year).
- Experience with training and/or monitoring and analytics in the bio/pharma industry preferred.
- In-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry preferred.
- Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility.
- Excellent communication skills, both oral and written.
- Excellent analytical skills, with a strong ability to draft and review documents, analyze and provide compliance guidance, and apply policy guidance to business needs.
- Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper ethical and compliance standards.
- Team-oriented, sound judgment, self-motivation and willingness to take initiative.
Benefits
- Stock options
- Restricted stock units
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401k retirement benefits
- Employer match
- Learning stipends
- Wellness stipends
- Paid time off
Company overview
Cytokinetics, Incorporated is a late-stage biopharmaceutical company headquartered in South San Francisco, California, specializing in muscle biology research and drug development. Founded in 1997 by leading scientists from Stanford, UCSD, and UCSF, the company focuses on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors for debilitating diseases characterized by impaired or declining muscle function. With over 25 years of scientific expertise, Cytokinetics has built a robust pipeline targeting cardiovascular and neuromuscular conditions including heart failure, hypertrophic cardiomyopathy, and amyotrophic lateral sclerosis (ALS). The company's innovative approach centers on directly targeting the sarcomere, the fundamental unit of muscle contraction, to develop potential treatments that may preserve and extend independence for patients. Cytokinetics operates as a publicly traded company (NASDAQ: CYTK) and has established itself as a leader in muscle biology with more than 115 publications, over 100 clinical trials, and hundreds of issued patents.