Senior Counsel - Compliance

Key Responsibilities

• 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
• 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

Qualifications

• Bachelor’s degree required; advanced degree preferred
• 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

Core Competencies

• 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
• Excellent communication and training capabilities
• 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

Travel

This position requires up to 10% travel. Frequently travel is outside the local area and overnight.

Benefits

• Medical
• Dental
• Vision
• Time off
• 401K

Pay

US Salary Range: $262,222 - $295,584

Schedule

This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.