Associate Director, Compliance & Privacy
Company: Denali
Location: South San Francisco
Posted on: July 10, 2025
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Job Description:
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.
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, Compliance
& Privacy, 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, regulatory
compliance, and data privacy as we prepare for our first potential
commercial launch in neurodegenerative disease. This position will
oversee compliance initiatives related to privacy law, data
governance, 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
Responsibilities Privacy & Data Governance Serve as the subject
matter expert on healthcare privacy laws (e.g., HIPAA, GDPR, CCPA)
and industry regulations affecting biotech companies. Collaborate
with Business Operations and IT to implement and oversee robust
data governance frameworks that ensure compliance with privacy and
security standards. Conduct privacy risk assessments, advise on
contractual privacy terms and data sharing agreements, and manage
any data privacy-related incidents. Implement appropriate privacy
controls for company activities, including marketing, digital
engagement, and patient assistance programs. Develop and lead
privacy related trainings to ensure functions across the business
are trained and empowered to act compliantly. Monitor evolving
global privacy laws and their impact on research, clinical trials,
and commercialization activities. 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. 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 Bachelor’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) Certification in Healthcare Privacy Compliance (CHPC)
Certified Information Privacy Professional (CIPP). Experience
working with compliance monitoring systems, transparency reporting
tools, and data privacy technology. Salary Range: $158,000.00 to
$200,667.00 . 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. 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.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.
Keywords: Denali, Turlock , Associate Director, Compliance & Privacy, Healthcare , South San Francisco, California