Senior Counsel, Commercial and Compliance

Overview

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

Responsibilities

Commercial Legal Leadership

• Act as the primary legal advisor to the Commercial and Medical Affairs teams.
• Provide strategic legal counsel during pre-launch and launch phases, balancing legal risks with business goals.
• Support commercialization readiness including promotional strategy, market access, patient services, and distribution models.
• Draft, review, and negotiate a variety of commercial agreements such as vendor contracts, patient support programs, speaker programs, distribution, and market access agreements.
• Lead legal review of promotional and medical materials through Medical Legal Review (MLR) and Promotional Review Committee (PRC) processes.
• Advise on interactions with healthcare professionals (HCPs), patients, payors, specialty pharmacies, and government entities.
• Support commercial and medical affairs activities including speaker programs, advisory boards, sponsorships, grants, medical information requests, and scientific exchange.
• Provide guidance on regulatory compliance in business activities such as disease education, HCP engagement, advisory boards, and patient-facing materials.

Compliance Program Build & Oversight

• Lead the design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance.
• Develop policies, procedures, training programs, and monitoring frameworks.
• Implement transparency and aggregate spend reporting processes.

Risk Management & Strategy

• Identify legal and compliance risks proactively and develop practical mitigation strategies.
• Monitor evolving healthcare laws, regulations, and industry trends.
• Provide clear, business-oriented guidance to senior leadership.

Broader Legal Support

• Support corporate legal matters and business development initiatives as needed.
• Manage external counsel effectively.
• Contribute to building a collaborative and high-impact legal team.

Qualifications

• Juris Doctor (J.D.) from an accredited law school.
• Active bar membership in at least one U.S. jurisdiction.
• 8–12+ years of legal experience in the biotech or pharmaceutical industry, preferably in-house.
• Proven experience supporting commercial build and product launch.
• Deep knowledge of healthcare and compliance laws and regulations including FDA, OIG, PhRMA Code, Anti-Kickback Statute, False Claims Act, Sunshine Act, etc.
• Strong experience with MLR/PRC review, promotional regulations, and compliance program development.
• Experience drafting and negotiating complex commercial agreements.
• Ability to operate effectively in a fast-paced, evolving environment with high accountability.

Leadership Profile

• Strategic, pragmatic, and solutions-oriented.
• Strong collaborator and influencer across all organizational levels.
• High integrity and sound judgment.
• Ability to balance urgency with quality.
• Hands-on builder capable of scaling processes as the organization grows.

Travel

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

Compensation & Benefits

• Salary range: $250,000 - $285,000 (U.S.)
• 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, experience, education, and skill level.

Location

• Fully remote position.