Position Summary:

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The Senior Director of Compliance will report directly to the SVP, Compliance and International Legal. This position will enhance and maintain all elements of an effective corporate compliance program globally, including policies, training, monitoring and investigations with specific focus on FCPA/UK Bribery Act, FDA regulations, fraud and abuse laws, OIG guidance and the PhRMA Code. The successful candidate will also be responsible for providing ongoing advice and counsel regarding United States (US) business operations, supporting employee questions and concerns, and partnering and collaborating with members from sales, marketing, medical affairs, patient advocacy, development, legal, and other business partners for all compliance related activities. The ideal candidate will have exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Build upon and maintain a corporate global compliance program, including conducting periodic risk assessments, drafting and reviewing policies, developing and providing training to all employees, establishing and executing a monitoring and auditing plan, implementing data analytics systems as needed, and investigating and maintaining records for employee investigations.
2. Lead compliance program governance, including setting annual priorities, establishing committee/working group cadence, defining escalation pathways, and providing clear, risk-based guidance to business leaders.
3. Provide strategic oversight for US HCP/HCO engagement controls (e.g., speaker programs, advisory boards, consulting, grants and donations), including fair market value, needs assessment, documentation standards, and transparency requirements.
4. Oversee U.S. field interaction compliance for commercial products, including development and delivery of targeted training, ongoing guidance to sales and field-based teams, and participation and compliance oversight of key commercial plan of action and execution meetings.
5. Manage intake, triage, and investigations of compliance allegations, ensuring consistent documentation, root-cause analysis, timely corrective and preventive actions (CAPA), and appropriate closure and learnings.
6. Serve as a strategic partner to US Commercial, Medical Affairs, Patient Advocacy, Market Access, and other stakeholders by reviewing and advising on high-risk activities, initiatives, and external communications.
7. Help determine appropriate risk-benefit strategy and tone for compliance-related activities, including but not limited late-stage pipeline programs and commercial products.
8. Working closely with other members of the Legal Department and other key stakeholders to establish proper strategic direction for compliance policies and programs.
9. With the Chief Legal Officer and SVP, Compliance and International Legal and other executive leadership team members, help develop and maintain the risk management program.

Requirements:

1. Education: BA/BS degree or equivalent required.
2. JD from a nationally recognized law school with strong academic credentials a plus.
3. 10+ years of experience in an in-house compliance role in the biotechnology or pharmaceutical industry or experience in a large to mid-sized law firm or consulting firm.
4. Knowledge and understanding of the required elements of global compliance programs, including enhancing the compliance function utilizing data analytics and artificial intelligence.
5. Experience in designing, building and implementing key components of a successful compliance program in a pharmaceutical/medical device company a plus.
6. Experience managing compliance programs in Europe and Latin America a plus.
7. Demonstrated senior leadership skills, including decisiveness, to analyze and define risk, and ability to appropriately communicate decisions to cross-functional groups and personalities.
8. High level of business ethics.
9. Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations.
10. Excellent interpersonal, written and oral communication skills.
11. Well-organized and hardworking, with the ability to manage numerous projects simultaneously under deadline pressure.
12. A high level of intellectual, professional and interpersonal agility and flexibility, combined with strong analytical and problem-solving skills.
13. Ability to form strong working relationships with partners and employees while maintaining firm adherence to proper legal standards.
14. Team oriented, with a good sense of humor, sound judgment, self-motivation and willingness to take initiative.
15. Domestic travel required (20%).

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