Senior Director, Regulatory Advertising and Promotion

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.

Senior Director, Regulatory Advertising & Promotion (Ad/Promo) is a highly motivated and strategic regulatory leader with deep expertise in promotional review and compliance. This individual will be accountable for leading Denali’s regulatory strategy and oversight for all promotional and non-promotional external communications across a portfolio of neuroscience programs. This leader is responsible for collaborating closely with cross-functional teams to ensure materials are compliant with Health Authority regulations and Denali policies while enabling the successful communication of product value to patients, providers, and payers.
This individual will oversee a growing team of regulatory professionals and serve as the internal expert on regulatory promotional standards, including FDA regulations and guidance. Denali is seeking a candidate with demonstrated experience in regulatory advertising and promotion, a collaborative and business-enabling mindset, and a commitment to integrity, innovation, and scientific excellence.

Key Accountabilities/Core Job Responsibilities:

• Developing and implementing regulatory Ad/Promo strategy for a portfolio of investigational and commercial products

• Serving as the Regulatory lead for promotional review committees (PRC/MRC), ensuring timely and compliant review of promotional and external communications

• Interfacing with cross-functional partners including Marketing, Medical Affairs, Legal, Compliance, and Clinical Development to provide strategic regulatory advice on promotional concepts, campaigns, and scientific communications

• Leading and executing FDA pre-submissions and post-submissions related to promotional materials, including advisory comments, 2253 submissions, and correspondence with the FDA OPDP or APLB

• Monitoring and interpreting evolving regulatory landscape, enforcement trends, and Health Authority guidance to proactively assess impact and support business strategy

• Developing internal regulatory policies, procedures, and training programs related to advertising and promotion

• Collaborating with external vendors and consultants to ensure compliance with regulatory promotional requirements

• Contributing to non-project related regulatory initiatives such as internal audits, inspection readiness, and compliance monitoring

• Mentoring and developing regulatory staff, fostering a culture of compliance, collaboration, and continuous improvement

• Upholding Denali’s values of scientific rigor, transparency, and ethical conduct

• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Qualifications/Skills

• Bachelor’s degree required; advanced degree in life sciences or relevant discipline strongly preferred

• 12+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with at least 8+ years specifically in regulatory advertising and promotion

• Prior experience leading promotional review for marketed products and late-stage pipeline assets

• Expert knowledge of FDA advertising and promotion regulations, including 21 CFR 202.1, FD&C Act, and applicable guidance documents (e.g., promotional labeling, social media, disease awareness)

• Demonstrated experience in direct engagement with FDA OPDP or APLB

• Strategic thinker with a strong understanding of the commercial landscape, scientific communication, and risk-based decision-making

• Excellent written and verbal communication skills, including the ability to influence across all levels of the organization

• Proven leadership experience in building, managing, and m