Senior Counsel - Compliance

- Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance to enable commercialization success

- Establish compliance governance, policies, procedures, standards, and risk management frameworks

- Implement transparency and aggregate spend reporting processes

- Proactively identify legal and compliance risks and develop practical mitigation strategies

- Monitor evolving healthcare laws, regulations, and industry trends

- Advise on compliance requirements related to HCP interactions, speaker programs, advisory boards, consultant engagements, grants, patient support programs, and medical education activities

- Provide guidance regarding the Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, PhRMA Code, and applicable state healthcare compliance laws

- Develop and oversee compliance monitoring, auditing, and testing programs

- Lead investigations of potential compliance concerns and oversee corrective and preventive action plans

- Create and maintain compliance guidance documents, SOPs, and training materials

- Oversee transparency reporting and related compliance obligations

- Monitor regulatory developments, enforcement trends, and industry guidance and assess impact on Company practices

- Collaborate with Legal, Regulatory, Privacy, Finance, and Human Resources teams on compliance governance initiatives

- JD, PharmD, MBA, MPH, or other relevant advanced degree preferred

- 12+ years of pharmaceutical, biotechnology, or life sciences compliance experience

- Significant experience building, implementing, or leading healthcare compliance programs

- Expertise in healthcare compliance laws and regulations, including the Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, and PhRMA Code

- Experience supporting commercial launch readiness and commercial-stage operations

- Experience conducting compliance risk assessments, investigations, monitoring, and auditing activities

- Experience developing and delivering compliance training programs

- Prior leadership experience within Compliance, Ethics, Legal, or related functions

- Experience within a pre-commercial or emerging biotechnology company preferred

- Strategic and proactive compliance leadership with strong business acumen

- Ability to influence senior leaders and drive a culture of ethics, integrity, and accountability

- Strong risk assessment, problem-solving, and decision-making skills

- Ability to balance compliance oversight with business partnership

- Demonstrated success operating in a lean, high-growth environment

- Executive presence and ability to interact effectively with senior leadership and Board members