Senior Director, Medical Information

Denali Therapeutics•South San Francisco, CA

9d•$248,000 - $277,000

About The Position

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. The Senior. Director, Medical Information will play a key role in building comprehensive medical information capabilities to ensure provision of accurate, balanced and timely scientific information to healthcare professionals, patients, and internal stakeholders. The ideal candidate will have experience with product launches, particularly in rare pediatric diseases.

Requirements

Doctorate level degree in scientific discipline required (PharmD, PhD, MD, or equivalent)
At or near 12 years’ experience in biotech/pharmaceutical industry with at least 7 years of relevant experience in Medical Information
Strong knowledge of global regulatory guidelines governing medical information activities.
Excellent communication and presentation skills with the ability to effectively translate complex scientific data for diverse audiences.
Proficiency in medical literature evaluation, database management, and medical information systems.
Strong analytical and problem-solving skills with attention to detail and the ability to synthesize data into meaningful communications.
Proven experience implementing or overseeing Med Info call center operations
Ability to thrive in a fast-paced environment, manage multiple priorities, and adapt to changing business needs.

Nice To Haves

Experience with product launches, particularly rare pediatric diseases preferred
Specialty training in rare disease and/or neuroscience preferred

Responsibilities

Define and drive the vision for Medical Information, including global medical inquiry management for Denali’s products.
Provide oversight for the Med Info call center to ensure quality, efficiency, scalability, and compliance.
Oversee the writing and quality of standard response documents (SRDs) and FAQs for the call center and facilitate the review, approval and maintenance of these documents.
Manage medical inquiry insights reporting with consistent visualization of trends/metrics
Manage budgets and forecast functional spend
Monitor emerging scientific data and competitor activity to keep medical information materials current.
Ensure Medical Information responses and processes are compliant with global regulatory requirements, industry guidelines, and Denali policies.
Collaborate with cross-functional teams to deliver training on medical information processes, resources, and best practices.
Serve as the medical information reviewer for medical and commercial review committees to ensure that medical information is accurate and scientifically balanced.
Represent Medical Information on cross-functional projects and during audits/inspections as needed.
Perform other Medical Information-related support and expanded functions, as required