Director - Compliance Counsel

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director - Compliance Counsel based in United States.

The Director - Compliance Counsel will serve as a senior legal and compliance advisor within a growing commercial biopharmaceutical organization.

This role will help shape and strengthen a practical, risk-based healthcare and corporate compliance program aligned with business objectives.

You will partner closely with leaders across Commercial, Medical Affairs, Regulatory, Clinical Development, Finance, HR, IT, and other functions.

The position combines strategic counsel with hands-on involvement in promotional review, investigations, training, policies, risk assessments, and monitoring.

You will translate complex healthcare regulations and evolving enforcement trends into clear, actionable guidance for business teams.

Success requires sound judgment, strong collaboration, independence, and the ability to build trust while upholding rigorous ethical standards.

This is an opportunity to influence compliance strategy while contributing to a patient-focused mission and a culture of integrity.

Accountabilities:

• Partner with senior compliance and privacy leadership to develop, implement, and maintain a scalable healthcare and corporate compliance program aligned with business activities, products, risks, and growth.
• Provide proactive, practical legal and compliance advice on commercial, medical, regulatory, corporate, and strategic initiatives across the organization.
• Advise on sales and marketing activities, promotional strategies, healthcare professional interactions, grants, sponsorships, transparency requirements, fraud and abuse considerations, and applicable healthcare laws and industry standards.
• Represent Legal and Compliance on promotional and medical review committees, providing guidance on advertising, educational, promotional, and medical materials and activities.
• Review financial and other interactions involving healthcare professionals, healthcare organizations, patients, payers, advocacy groups, distributors, and other relevant third parties.
• Support product development and commercialization activities, including regulatory and medical strategies, product safety considerations, product liability assessments, and risk mitigation.
• Develop and update compliance policies, procedures, standards, and guidance in collaboration with business and functional stakeholders.
• Support executive compliance governance by preparing materials, reporting on key matters, and following up on actions and commitments.
• Design and deliver engaging compliance and ethics training for employees, leaders, contractors, and external consultants through both live and role-specific educational programs.
• Promote a strong culture of compliance, ethics, accountability, and speak-up practices across the organization.
• Conduct or support internal investigations into potential violations of laws, regulations, or company policies while maintaining confidentiality and recommending appropriate corrective and preventive actions.
• Support compliance risk assessments, monitoring, auditing, remediation activities, and other oversight initiatives for key risk areas.
• Participate in reviews involving grants, continuing medical education, investigator-initiated studies, sponsorships, and related activities as appropriate.
• Monitor changes in legislation, regulations, enforcement trends, and industry practices, translating developments into practical policies, training, guidance, and risk mitigation strategies.
• Identify emerging legal and compliance risks and collaborate across functions to implement effective, business-focused solutions.
• Manage external counsel and other advisors efficiently when specialized expertise is required.

Requirements:

• Juris Doctorate or equivalent law degree and admission to a State Bar.
• 5-7+ years of professional legal experience within a law firm or in-house legal department, with significant experience supporting the life sciences industry; experience appropriate for a Director or Executive Director-level position is preferred.
• Direct experience advising a public biopharmaceutical or comparable life sciences organization on healthcare and compliance matters, including product promotion, commercial contracting, healthcare professional interactions, investigations, training, risk assessments, monitoring, and policy implementation.
• Strong knowledge of pharmaceutical and healthcare regulations, including the FDCA, FDA guidance, fraud and abuse and anti-kickback requirements, OIG guidance and advisory opinions, PhRMA guidelines, state marketing and transparency laws, and relevant privacy requirements.
• Experience reviewing promotional and medical materials and participating in Promotional and Medical Review processes.
• Demonstrated ability to develop and implement compliance policies, training programs, risk assessments, monitoring plans, and other components of an effective healthcare compliance program.
• Experience conducting or overseeing internal investigations and developing corrective and preventive actions is a plus.
• Familiarity with managed markets, payer and PBM contracting, patient support programs, government pricing, grants, investigator-initiated studies, or sponsorships is advantageous.
• Strong independent judgment, integrity, discretion, and the ability to balance commercial objectives with legal and compliance obligations.
• Proven ability to build trusted relationships, influence senior leaders, and drive sound decisions in a dynamic and innovative environment.
• Excellent analytical, problem-solving, organizational, and attention-to-detail skills, with the ability to manage deadlines effectively.
• Exceptional written, verbal, presentation, interpersonal, and collaboration skills.
• Ability to translate complex regulatory concepts into clear, practical recommendations for diverse stakeholders.
• A collaborative, inclusive, adaptable, and solutions-oriented mindset with a strong commitment to ethical conduct and patient-focused outcomes.

Benefits:

• Salary range of $241,988-$276,900, with compensation determined based on relevant qualifications, experience, and other job-related factors.
• Excellent overall benefits package.
• Health and wellness benefits designed to support employees and their families.
• Opportunities to work in San Diego, California; Boston, Massachusetts; or remotely within the United States.
• Professional growth and career development opportunities within a science-driven organization.
• Opportunity to contribute to innovative healthcare solutions and initiatives focused on improving outcomes for patients with serious diseases.
• Collaborative and inclusive work environment that values diverse perspectives, expertise, and professional growth.
• Engagement in meaningful compliance, ethics, and business initiatives with broad organizational visibility.