We are representing an international pre-commercial biotechnology company in their search for a Chief Compliance Officer.
Why Join Us:
- Opportunity to build the global compliance program of a well-financed publicly traded biotechnology company
- Multi-product business including a groundbreaking product submitting BLA in 2021
- Established culture of integrity, collaboration and ethical business practice from the top down
Expectations first 12 months:
- Conduct enterprise-wide risk assessment, plan and execute a framework for developing a full best-in-class compliance program
- Establish and chair a Board Compliance Committee as well as a Management Compliance Committee
- Planning and execution of pre and post-commercialization compliance plans as product one comes to market
Responsibilities:
- Reporting directly to the CEO with dotted line and collaborative relationships with the General Counsel and Board of Directors; Responsible for developing, implementing and managing compliance, ethics and privacy programs across the group in all geographies
- Regulatory and legal focus including but not exclusive to Federal Drug Authority (FDA) rules and guidance, Sunshine Act, EFPIA Code and associated national codes of practice, UK PMCPA Code and PhRMA
- Promoting, and engaging employees and directors with the compliance agenda, its strategic importance to the business and its relationship to the company’s values and goals
- Designing and maintaining a suite of policies and procedures suitable for a global, commercial-stage biotech
- Establishment and leadership of Board and management Compliance Committees; Membership of other compliance-related committees, e.g. Grants and Donations Committee
- Maintaining an effective and uniform compliance training and communications program
- Maintaining effective lines of communication between employees and postholder, and postholder and management / Board, key internal contact for compliance complaints and other compliance matters
- Auditing levels of compliance and seeking opportunities for improvement, auditing outsourced elements of the compliance program e.g. US government rebate reporting
- Enforcing standards as necessary, including via investigations and contractual or disciplinary measures
- Proactively identifying and mitigating existing and emerging compliance risks
- Operational work reviewing promotional / pre-promotional materials and agreements concerning dealings with Healthcare Professionals (HCPs), seeking to achieve all business goals via acceptable routes
- Managing the procurement of external compliance advice and services via outside counsel and service providers as required
- Managing privacy and data protection programs in conjunction with legal and technology teams
Qualifications:
- Essential Education: Bachelor’s Degree
- Significant executive level biotechnology / pharmaceutical compliance experience, with demonstrable exposure to building and significantly improving international compliance programs
Application Process for Chief Compliance Officer: Qualified professionals are to submit resume to Steve Harrison: steve@conselium.com
Published by Conselium Executive Search, the global leader in compliance search.
