Overview
A clinical-stage biopharmaceutical organization focused on developing medicines targeting hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone is seeking a Senior Counsel - Commercial Legal. The company’s initial product candidate is lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor. The organization operates fully remotely.
Responsibilities
- Serve as the primary legal advisor to the Commercial and Medical Affairs teams.
- Provide strategic legal counsel across pre-launch and launch activities, balancing legal risk with business objectives.
- Support commercialization readiness, including promotional strategy, market access, patient services, and distribution models.
- Lead legal review of promotional and medical materials through promotional review committee (PRC) and medical review committee (MRC) processes.
- Advise on interactions with healthcare professionals (HCPs), patients, payors, specialty pharmacies, and government entities.
- Support commercial and medical affairs activities such as speaker programs, advisory boards, sponsorships, grants, medical information requests, and scientific exchange.
- Provide guidance on compliance with regulatory requirements in business activities including disease education, HCP engagement, advisory boards, and patient-facing materials.
- Draft, review, and negotiate a wide range of commercial agreements including those related to vendors, patient support programs, speaker programs, distribution, and market access.
- Support corporate legal matters and business development initiatives as needed.
- Manage external counsel effectively.
Requirements
- Juris Doctor (JD) degree from an accredited law school.
- Active membership in at least one U.S. state bar.
- Minimum of 10 years of legal experience within the pharmaceutical, biotechnology, or life sciences industry.
- Strong knowledge of FDA advertising and promotion regulations and commercial legal requirements.
- Experience with product launch planning and commercialization activities.
- Ability to support Medical Affairs organizations and scientific exchange initiatives.
- Expertise in drafting, reviewing, and negotiating complex commercial agreements.
- Experience working within a pre-commercial or emerging biotechnology company is preferred.
Core Competencies
- Strong business judgment with a practical, solutions-oriented approach to risk management.
- Ability to balance legal risk mitigation with commercial objectives.
- Capability to influence and advise senior leaders in a matrixed environment.
- Excellent communication skills, able to translate complex legal and regulatory concepts into actionable business guidance.
- Strong cross-functional collaboration and relationship-building skills.
- Demonstrated ability to operate effectively in a fast-paced, resource-constrained environment.
- High degree of autonomy, accountability, and execution focus.
Compensation & Benefits
- US Salary Range: $262,022 - $295,584
Location
- Fully remote position based in the United States.