Chief Compliance Officer

CHIEF COMPLIANCE OFFICER

Position Summary:

Global Blood Therapeutics (GBT) is seeking a seasoned compliance professional to create and lead the Company's internal healthcare compliance function. The Chief Compliance Officer (CCO) is responsible, for designing, implementing and maintaining an effective Compliance Program, and ensuring that a culture of compliance permeates the organization at all levels. The CCO ensures that the company and its employees comply with applicable healthcare-related laws and regulations. The CCO reviews and evaluates compliance issues/concerns; monitors, audits and reports on healthcare compliance/ethics efforts; and is responsible for building and leading multi-disciplinary efforts within the company related to healthcare compliance. The CCO must exhibit the highest level of integrity and ethics. This position reports to the Chief Legal Officer (CLO) and the Chief Executive Officer.

Essential Duties and Responsibilities:

• Develops GBT's healthcare compliance department, professionals and infrastructure from the ground up (including managing outside vendors as part of our current compliance build), with a particular focus on creating and implementing an effective Compliance Program for all activities relating to healthcare practitioners, patients, medical affairs/MSLs and commercialization
• Works collaboratively with Legal team partners (especially CLO and VP, Commercial Product Law) and key functions within GBT on all topics relating to healthcare compliance (including marketing/commercial, medical and regulatory affairs, clinical, patient support/advocacy, finance and human resources)
• Partners with functional teams to establish a rapport and positive working relationship with respect to compliance initiatives at GBT
• Works collaboratively and creatively with stakeholders and provides broad spectrum compliance support and day-to-day counseling. Clearly and effectively renders practical, timely advice
• In connection with developing an effective Compliance Program at GBT:
  • Institutes appropriate policies and procedures and ensures its related activities are created, adopted, published, and communicated to staff
  • Develops, coordinates, and administers effective compliance training programs for all appropriate employees and management on pertinent laws, regulations, policies and procedures, including in-depth training of key functions and field personnel
  • Ensures that compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved, that there are effective and consistent disciplinary systems and evaluation/ incentive systems that promote legal and ethical conduct
  • Develops and implements auditing, monitoring, and reporting programs
  • Develops and implements period and annual sign-offs as needed under federal and state transparency requirements
  • Establishes and implements periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk
  • Develops and implements preventative and corrective action plans to mitigate identified risks.
  • Responds to alleged violations by evaluating or recommending the initiation of investigative procedures, designing and implementing investigative protocols and overseeing investigation processes
  • Partners actively with senior executives to instill a strong culture of compliance at the company through communications and outreach activities
  • Provides reports on a regular basis, and as directed or requested, to keep GBT's Compliance Committee, CLO, CEO and other senior management and the Board of Directors informed of the operation and effectiveness of the Compliance Program

• Maintains a very strong working knowledge of applicable laws, regulations, and enforcement actions to identify emerging risks
• Alerts the Company to trends and risks and assists in implementing policies and procedures in response thereto
• Periodically reviews and updates the Code of Ethics and Business Conduct to ensure continuing relevance in providing guidance to management and employees
• Manages outside vendors to achieve timely and cost-effective work

Qualifications:

• 10-15 years in-house experience as a compliance professional in the life sciences industry required, preferably at a pharmaceutical or biotech company
• Broad experience with US healthcare compliance; experience with global compliance preferred
• Experience with privacy compliance preferred
• Demonstrated experience launching new compliance programs, from inception to implementation and beyond
• Excellent communication, negotiation, training and presentation skills and ability to interact with all levels of the organization
• Strong organizational, project-management and teamwork skills required
• Self-motivated, innovative, strategic, detail-oriented and able to provide high quality and timely work product
• Able to manage multiple projects and work successfully in a fast-paced environment under time deadlines
• Ability to analyze issues and propose options and recommended course of action
• Ability and track record of successfully working in cross-functional teams
• Strong client service orientation and business acumen
• Demonstrated success in a fast-paced, high-performing, fluid, and collaborative culture
• Ability work to collaboratively with individuals having diverse educational and cultural backgrounds
• Ability to communicate effectively with personnel at all levels of the organization and to inspire confidence and support for compliance initiatives
• Strong working knowledge of relevant statutes, regulations, guidances/precedents and trends
• Proven ability to think strategically about achieving corporate objectives by addressing the needs of internal and external stakeholders
• Ability to travel as necessary

Fit with GBT Culture and Values:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.