Senior Counsel – Compliance

Overview

A clinical-stage biopharmaceutical organization focused on developing treatments for hypertension and related comorbidities such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA) is seeking a Senior Counsel - Compliance. The company’s lead product candidate is an orally administered, highly selective aldosterone synthase inhibitor. The organization operates fully remotely.

Responsibilities

• Lead the design, implementation, and oversight of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance to support commercial launch readiness and ongoing operations.
• Establish compliance governance structures, 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.
• Provide compliance guidance related to healthcare professional (HCP) interactions, speaker programs, advisory boards, consultant engagements, grants, patient support programs, and medical education activities.
• Advise on compliance with the Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, PhRMA Code, and applicable state healthcare laws.
• Develop and oversee compliance monitoring, auditing, and testing programs.
• Lead investigations of potential compliance concerns and manage corrective and preventive action plans.
• Create and maintain compliance guidance documents, standard operating procedures (SOPs), and training materials.
• Oversee transparency reporting and related compliance obligations.
• Monitor regulatory developments, enforcement trends, and industry guidance to assess impact on company practices.
• Collaborate with Legal, Regulatory, Privacy, Finance, and Human Resources teams on compliance governance initiatives.

Requirements

• Bachelor’s degree required; advanced degree preferred (JD, PharmD, MBA, MPH, or other relevant advanced degree).
• Minimum of 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.
• 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 promote 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

• Up to 10% travel required, often outside the local area and overnight.

Compensation & Benefits

• US Salary Range: $262,022 - $295,584.
• Eligible for standard benefits including medical, dental, vision, time off, and 401(k).
• Participation in incentive plans contingent on personal and company performance.
• Actual compensation may vary based on geographic location, work experience, education, and skill level.

Location

• Fully remote position.