Associate Director, CMPA Operations

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 is seeking a highly skilled and experienced Associate Director, Program Review and Business Operations who will be responsible for leading key operational functions within Commercial, Medical Affairs, Public Affairs and Access. This role will develop and implement best practices to enhance program review and business operations, efficiency, governance, and execution.

Key Accountabilities/Core Job Responsibilities:

Promotional Review Operations

• Lead and manage the US and Global program review process (promotional and non-promotional), including coordination of review meetings, routing of materials, and tracking deliverables.

• Collaborate with Regulatory, Legal, Medical, and Commercial stakeholders to ensure consistent, compliant, and timely review of promotional and non-promotional materials.

• Implement and manage systems for material routing and approval (e.g., Veeva PromoMats or similar platforms).

• Develop, maintain, and enhance review workflows and standard operating procedures (SOPs).

• Conduct training and onboarding for internal stakeholders on promotional review processes and compliance requirements.

Compliance Operations

• Monitor evolving regulatory guidance and enforcement trends, working with legal/compliance to update policies and practices as necessary.

• Build and implement processes for transparency reporting (e.g. Sunshine Act Reporting, State Transfer of Value Reporting).

• Ensure field personnel are trained and certified; Maintaining training records and re-certification schedules.

• Establish processes for HCP engagement activities such as Ad Boards and Speaker Bureau programs.

• Support compliance monitoring, including field activity monitoring to ensure timely, accurate, and compliant documentation of interactions.

• Establish processes for issues reporting and escalation.

• Support internal audits and inspection readiness activities related to materials review and compliance operations.

• Drive continuous improvement initiatives to enhance review efficiency, quality, and cross-functional collaboration.

• Develop regular reports and presentations for senior leadership, summarizing operational performance, project progress, and key issues; provide actionable insights to improve business outcomes, informed by data and operational metrics.

Qualifications/Skills:

• Bachelor's degree in Business Administration, Operations Management, or a related field; PMP Certification, MBA, or advanced degree preferred.

• 7 years of relevant work experience, including 5 years in business operations, project management, or similar roles, with a proven track record supporting cross-functional leadership teams.

• Experience working in or with Commercial, Medical Affairs, Public Affairs and Access functions (preferably in the healthcare, pharmaceutical, or biotech industry). Global experience is a plus.

• Experience with the Veeva system is strongly preferred, including, materials management, CRM, etc.

• Knowledge of pharmaceutical industry regulations and compliance frameworks.

• Pharmaceutical product launch experience preferred.

• Strong project management skills with the ability to manage multiple initiatives simultaneously.

• Exceptional communication skills (verbal and written) and the ability to collaborate with and influence senior executives and stakeholders at all levels.

• Strong drive for results; Ability to work in a fast-paced, dynamic environment, navigating organizational structures by serving as a connector and catalyst driving decisions and impact with urgency.

• Collaborative and adaptable team player with a problem-solving mindset.

• Systems thinker who sees interdependencies and implications and solves for the whole.

• Effective at simplifying and challenging processes and complexity, to make way for efficient ways of working across the organization.

Salary Range: $188,000.00 to $237,333.00 . 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.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.