Associate Director, Healthcare Compliance

Denali Therapeutics; South San Francisco (CA); On-site; USD 159,000 - 207,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad range of other benefits

Job summary

Denali Therapeutics is seeking an Associate Director, Healthcare Compliance to lead FMV assessments, Transfer of Value reporting, and price transparency initiatives. You will partner with Finance, Contracts, Market Access, and IT to ensure adherence to HIPAA, GDPR, and global regulations.

You will design training programs, oversee audits, investigations, and policy development while translating complex compliance requirements into practical solutions across the organization.

Qualifications

• Bachelor’s degree required; JD/MBA/Master’s preferred.
• 5+ years of compliance or regulatory experience in biotech/pharma.
• Strong knowledge of HIPAA, GDPR, Anti-Kickback Statute, False Claims Act, Sunshine Act, and price transparency laws.
• Experience with FMV assessments and Transfer of Value reporting.
• Experience designing and delivering compliance training.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Oversee FMV assessment process for payments to healthcare professionals.
• Oversee Transfer of Value reporting across state, federal, and global levels.
• Ensure compliance with state price transparency reporting laws.
• Provide compliance oversight for investigator-initiated trials, sponsorships and advisory boards.
• Implement auditing/monitoring programs and lead investigations.
• Conduct risk-based compliance assessments and report findings to leadership.
• Develop and deliver compliance training and update policies.

Skills

Communication

Analytical skills

Interpersonal skills

Cross-functional collaboration

Education

Bachelor’s degree

JD/MBA/Master’s preferred

Tools

FMV calculators

Compliance monitoring systems

Job description

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.Denali Therapeutics is recruiting an Associate Director, Healthcare Compliance, reporting to the Executive Director, Healthcare Law and Compliance. This position will play a pivotal role in supporting the organization’s commitment to ethical business practices and regulatory compliance. 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 ResponsibilitiesHealthcare Compliance & Financial TransparencyOversee 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., state, federal, global), 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.Auditing/Monitoring & InvestigationsImplement 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 DevelopmentDevelop 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 programsQualifications & RequirementsBachelor’s degree required; JD, MBA, or Master’s in a related field preferred.At or near 7 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, GDPR, 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.Preferred Qualifications:Certification in Healthcare Compliance (CHC), or similarExperience working with compliance monitoring systems, transparency reporting tools, and FMV calculatorsExperience scaling compliance programs in the U.S. and globallySalary Range: $159,000.00 to $207,000.00 . 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/careersThis 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.