Director, Healthcare Compliance

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

Denali Therapeutics is recruiting a Compliance Counsel, reporting to the Senior Director, Healthcare Law and Compliance. This role will play a pivotal role in supporting the organization’s commitment to ethical business practices, and regulatory compliance as we prepare for our first potential commercial launch in neurodegenerative disease. This position will oversee compliance initiatives related to Fair Market Value (FMV) payments, Transfer of Value reporting, price transparency reporting, auditing/monitoring, investigations, training, and policy development. The role requires cross-functional collaboration with Business Operations, Finance, IT, Contracts, Market Access, and other stakeholders to ensure adherence to federal, state, and global regulations.

Key Accountabilities/Core Job Responsibilities:

Healthcare Compliance & Financial Transparency

• Oversee the Fair Market Value (FMV) assessment process to ensure payments to healthcare professionals (HCPs) align with regulatory requirements and company policies; serve as the point of escalation with the Contracts Group.

• Oversee the Transfer of Value reporting process (e.g., CMS Open Payments, state reporting), including tracking, identifying, and remediating discrepancies in collaboration with Business Operations.

• Ensure compliance with state price transparency reporting laws in partnership with Market Access.

• Provide compliance oversight for activities including investigator-initiated trials, sponsorships and grants, and advisory boards.

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Auditing/Monitoring & Investigations

• Implement auditing and monitoring programs to proactively identify and mitigate compliance risks in interactions with HCPs and commercial activities.

• Lead and support internal investigations related to potential compliance violations, ensuring proper documentation, root cause analysis, and corrective action implementation.

• Conduct risk-based compliance assessments to evaluate the effectiveness of policies and controls, reporting findings and recommendations to leadership.

Training & Policy Development

• Develop and deliver compliance training to employees, ensuring understanding of biotech-specific compliance risks and regulatory obligations.

• Develop and update company compliance policies and procedures based on tracking changes in the regulatory and enforcement landscape.

• Provide strategic guidance on emerging healthcare compliance risks, including clinical trials, patient support programs, expanded access programs, and commercialization strategies.

Qualifications & Requirements

• J.D. degree from an accredited law school preferred. 

• Active California bar membership in good standing. 

• Typically 10 years of overall work experience, to include 5+ years of compliance or regulatory experience in the biotech, pharmaceutical, or life sciences industry.

• Strong knowledge of U.S. and global healthcare compliance regulations, including HIPAA, Anti-Kickback Statute, False Claims Act, Sunshine Act, and state price transparency laws.

• Experience with FMV assessments, Transfer of Value reporting, price transparency regulations, and industry compliance best practices.

• Experience designing and delivering compliance training programs.

• Strong investigative skills with experience in auditing, monitoring, and risk management.

• Excellent communication, analytical, and interpersonal skills, with the ability to work cross-functionally.

• Ability to be flexible and adapt with a growth mindset while providing practical compliance solutions to complex challenges.

• Motivated to communicate strategy and report on results to build trust and transparency at all levels of the company.

• Ability to be onsite in our South San Francisco office 3 days per week (8 hours per day).

Preferred Qualifications

• Certification in Healthcare Compliance (CHC)

• Experience working with compliance monitoring systems and transparency reporting tools.

Salary Range: $251,000.00 to $309,667.00 .  Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
 

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.