Why Join Us:
• Client is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.
• Aiming to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
• Take a leadership role in enhancing, scaling and maintaining our global compliance program.
• This is an exciting opportunity to join a rapidly growing company that is significantly expanding its global footprint and to help shape the compliance function to support such growth.
What to Expect:
In this senior role, you will make an impact on the continued development of the compliance program; spearhead major initiatives and projects; and develop, grow and lead a staff that is critical to the smooth and compliant functioning of company’s global business. The Senior Director, Compliance Program will be responsible for the company’s compliance efforts relating to our internal code of business conduct, anti-bribery/anti-corruption laws, anti-kickback statutes, privacy regimes and other country-specific laws and regulations, with a focus on overseeing HCP interactions and engagements. To support the company’s continued growth outside the U.S., you will work proactively with other departments and regions and add rigor to existing processes to support global expansion in a compliant manner.
The Senior Director, Compliance Program will report to the General Counsel/Chief Compliance Officer.
Responsibilities:
The Senior Director, Compliance Program is responsible for ensuring the company engages in compliant behavior with regards to:
• Interactions and arrangements with HCP speakers and consultants;
• Its global network of distributors, agents, suppliers and other significant business partners;
• Transparency Reporting (global);
• Its handling information protected by HIPPA and privacy laws (both state-, country- and EU-specific);
• Employee conduct in accordance with the company’s Code of Business Ethics and other policies; and
• Document retention practices in accordance with company policy and schedule.
Daily Activities:
The day-to-day responsibilities of the Senior Director, Compliance Program includes:
• Owns the development, implementation and ongoing improvement of the company’s compliance program;
• Serve as the company resource for compliance developments and matters and provide business guidance to mitigate risk;
• Manage compliance policies, guidance and SOP’s in accordance with growing and evolving business needs and applicable regulations;
• Supervise compliance investigations from intake to resolution; collaborate with other functions and departments to provide recommendations; and ensure corrective actions are implemented;
• Develop and coordinate compliance-related communications, education and training activities for employees and third parties;
• Manage due diligence on international distributors from FCPA compliance perspective;
• Develop, drive and oversee a program of compliance tracking and monitoring activities;
• Chair and lead the Compliance Committee;
• Design and deliver meaningful, accurate and effective presentations to senior management and the Board of Directors, including the Audit Committee, and ensure follow-up on any areas that require corrective action;
• Work with outside counsel, consultants and vendors and recommend such partnering if and when needed;
• Manage and develop team members that are responsible for conducting the day-to-day processes, as well as serve as a first-level escalation point for questions and issues;
• Support spot or company-wide audits of the compliance program; and
• Travel as needed.
Requirements:
• At least twelve years of relevant compliance experience with an healthcare compliance focus;
• Experience with a global life-sciences company or healthcare consulting firm with emphasis in life sciences;
• Bachelor’s Degree, advanced or credential preferred;
• Ability to recognize compliance risk and develop workable strategies to mitigate such risk
• In-depth knowledge of U.S. and foreign laws, regulations, and codes relevant to HCP interactions, including anti-corruption (U.S. Foreign Corrupt Practices Act, UK Bribery Act and other OUS statutes), anti-kickback, transparency reporting (U.S. Physician Payment Sunshine Act and OUS statutes), False Claims Act, Stark Law, and the AdvaMed and MDMA Codes;
• Demonstrated management, leadership and executive capabilities with strong presentation skills;
• Demonstrated success building and leading a global compliance program;
• Ability to prioritize and direct limited resources to the most critical areas and issues; build solid, collaborative working relationships across multiple functions and levels of management in the U.S. and around the globe; and drive improvement initiatives with a sense of urgency;
• Comfort working in a fast-paced, dynamic organization and supporting a rapidly-growing business;
• Sound judgment, political acumen and ability to clearly and succinctly articulate position and rationale to others; and
• Desire to be a leader amongst the compliance industry
This position can be remote, but if remote, the position would require periodic travel to our headquarters in Santa Clara, CA.
Qualified professionals are to submit resumes to Jessica Simpson at jessica@conselium.com
Published by Conselium Executive Search, the global leader in compliance search.
