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 Director, Toxicology will play a critical role in supporting the nonclinical safety assessment of therapeutics within Denali's pipeline. This position involves conducting and managing toxicology studies, analyzing and interpreting safety data, and collaborating with cross functional teams to advance drug candidates through various stages of development.

Key Accountabilities/Core Job Responsibilities:

Nonclinical Toxicology Support:

Design and implement nonclinical toxicology program and strategies to evaluate the safety of Denali's therapeutic candidates.
Conduct and oversee non-GLP and GLP toxicology studies, utilizing CRO's, ensuring adherence to regulatory standards.

Data Analysis and Reporting:

Analyze, interpret, and summarize toxicology data to support safety evaluations.
Prepare and present safety data to internal project teams and senior management, as well as contributing to informed decision-making.
Define and communicate clinical safety. and regulatory risks associated with nonclinical safety findings, including ramification on development plan.

Regulatory Support:

Assist in the preparation and authoring of regulatory documents related to nonclinical safety assessments.
Ensure compliance with relevant regulatory guidelines and standards throughout all stages of toxicology studies.
Participate in meetings with international Health Authorities supporting development and approval of Denali's therapeutic candidates.

Collaboration and Cross Functional Work:

Work closely with colleagues in Research and Development, providing toxicology expertise to support cross-functional project teams.
Participate in project meetings, offering insights and recommendations to advance safety assessment strategies.
Development and coauthoring of integrated drug development plans for novel therapeutics and indications.

Investigative Efforts:

Support investigative efforts into mechanisms of toxicity and contribute to the development of safer therapeutic candidates when needed.
Assist in developing and implementing de-risking strategies for drug discovery and development projects.

Qualifications/Skills:

PhD in Toxicology or related scientific discipline. DABT is preferred.
At or near 10 plus years of relevant work experience inclusive of postdoctoral work; OR MS with 14+ years of relevant work experience.
Experience with biologic and oligonucleotide therapeutics preferred
Strong scientific background and scientific aptitude
Excellent critical thinking and problem solving skills
Ability to work effectively and collaboratively on cross-functional projects teams, and demonstrated can-do attitude
Ability to work in a fast-paced dynamic environment
Excellent oral, presentation, and written communication skills

Salary Range: $204,000.00 to $258,667.00 . 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. 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.