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.
About the Role
Please note this is a pipeline requisition for a role we expect to open later this year.
We are looking for a Compliance Operations Manager with deep, hands-on knowledge of the ethics and compliance requirements that apply to the pharmaceutical industry in Europe to support and strengthen our compliance program across our European markets.
With support of your manager, you will design the monitoring framework and transparency processes. You will be responsible for the day-to-day operation of the European compliance program, including administration of key compliance processes and execution of monitoring activities and other controls.
You will work cross-functionally with various European and country teams to ensure that policies, SOPs and processes are understood, followed consistently, and continuously improved, while acting as a trusted point of contact for compliance process questions across European countries.
Key Responsibilities
- Manage day-to-day operations of our compliance program, translating compliance requirements into practical, workable business processes that drive operational compliance excellence across European markets
- Conduct routine monitoring (e.g., expense reports, HCP/HCO transactions, live events) and compliance controls, produce monitoring reports and recommend corrective actions, tracking them through closure
- Track and report on compliance metrics, KPIs, and program effectiveness
- Develop and deploy trainings on compliance processes; coordinate recurrence and logistics of compliance trainings (scheduling, tracking completion)
- Own the end-to-end annual transfers of value disclosure cycle across the relevant European countries – data collection, HCP/HCO consent and privacy notices, validation, local sign-off and publication – under both the statutory regimes and the EFPIA Disclosure Code as relevant for our company
- Support investigations into potential compliance violations, under the direction of Compliance and Legal leadership, including data gathering, documentation, and follow-up on corrective actions
- Administer the review and approval process for key compliance activities
- Maintain the European policies and SOPs lifecycle: drafting, periodic review, local adaptation, translation management and controlled distribution
- Stay current on compliance developments across European jurisdictions and assess their operational impact
Qualifications
- Bachelor's degree in a relevant field (Life Sciences, Law, Business, or related discipline) - preferred, or professional certification in compliance or ethics (e.g., CCEP-I)
- 7+ years of experience in compliance, ethics, internal audit within the pharmaceutical, biotech, or life sciences industry including demonstrable experience operating a compliance program across several European countries
- Ability to apply compliance knowledge in real time - recognizing red flags, assessing severity, and routing issues to the right resolution path
- Experience with desktop and live monitoring; ability to pull and interpret data to drive process optimization and to spot issues before they escape
- Hands‑on experience running transfers of value disclosure in more than one European country, with working knowledge of both the statutory regimes and the EFPIA Disclosure Code Working knowledge of the European pharmaceutical compliance frameworks (EFPIA Code of Practice, relevant national codes of practice such as FSA, ABPI, Farmindustria or Farmaindustria); knowledge of anti-bribery/anti-corruption laws relevant to healthcare including UK Bribery Act, US FCPA
- Working knowledge of privacy and GDPR as it bears on compliance work (lawful basis and consent for transfer of value publication, HCP privacy notices)
- Attention to detail balanced with big-picture thinking; strong organizational skills with the ability to manage multiple workstreams across several countries simultaneously
- Ability to prioritize and to work independently while collaborating effectively across functions and cultures
- Pragmatic approach, with the strong ability to drive to solutions
- Excellent written and verbal communication skills with the ability to explain compliance concepts clearly to non-specialist audiences
- Languages: English (proficient – written and spoken) is essential; at least one additional European language relevant to our markets is an advantage (German preferred)