Associate Director, Toxicology at Denali Therapeutics

South San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Neurodegenerative diseasesIndustries

Requirements

PhD OR Advanced Degree in Toxicology, Biology, Pharmacology or related scientific discipline
At or near 7+ years of relevant work experience inclusive of postdoctoral work; OR MS with 10+ years of relevant work experience
Experience with biologics and oligonucleotides preferred
Strong scientific background and scientific aptitude
Excellent critical thinking and scientific skills
Ability to work effectively and collaboratively on cross-functional project teams, and demonstrated can-do attitude
Ability to work in a fast-paced environment
Excellent oral, presentation, and written communication skills

Responsibilities

Design and implement nonclinical toxicology programs and strategies to evaluate the safety of Denali's therapeutic candidates
Conduct and oversee non-GLP and GLP toxicology studies, ensuring adherence to regulatory standards
Analyze, interpret, and summarize toxicology data to support safety evaluations
Prepare and present safety data to internal project teams and senior management, contributing to informed decision-making
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
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
Support investigative efforts into mechanisms of toxicity and contribute to the development of safer therapeutic candidates
Assist in developing and implementing de-risking strategies for drug discovery and development projects
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

Skills

Key technologies and capabilities for this role

ToxicologyGLP studiesNon-GLP studiesSafety assessmentData analysisRegulatory compliancePeople leadershipDrug development

Questions & Answers

Common questions about this position

What qualifications are required for the Associate Director, Toxicology role?

Candidates need a PhD or advanced degree in Toxicology, Biology, Pharmacology or related scientific discipline, with at or near 7+ years of relevant work experience including postdoctoral work, or an MS with 10+ years.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

Does this role involve people leadership?

Yes, the role serves as a functional leader for the Toxicology team and includes people leadership accountability for one or more Toxicologists, involving annual goal setting, growth planning, and providing feedback.

What experience makes a strong candidate for this position?

Strong candidates will have a PhD or advanced degree in a relevant field with 7+ years of experience in nonclinical toxicology, including designing toxicology programs, managing GLP studies, data analysis, regulatory support, and cross-functional collaboration.

Denali Therapeutics

Develops treatments for neurodegenerative diseases

About Denali Therapeutics

Denali Therapeutics focuses on finding and developing treatments for neurodegenerative diseases like Alzheimer's, Parkinson's, and ALS, which involve the gradual loss of nerve cells and can lead to serious physical and mental challenges. The company uses scientific research to understand the biological pathways that lead to these diseases, aiming to create drugs that target specific molecules in the body to treat them. Denali stands out from its competitors by combining its own research efforts with partnerships with other biotech firms and pharmaceutical companies, allowing it to share risks and access new technologies. The goal of Denali Therapeutics is to create effective treatments that improve the lives of patients suffering from these debilitating conditions.

South San Francisco, CaliforniaHeadquarters

2015Year Founded

$337.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Risks

Failure in ALS trials raises concerns about pipeline efficacy.

Increased competition in ALS treatment could impact market share.

Discontinuation of programs due to toxicities highlights potential development challenges.

Differentiation

Denali focuses on neurodegenerative diseases like Alzheimer's, Parkinson's, and ALS.

The company employs a science-driven approach to translational medicine and clinical development.

Denali leverages partnerships to access new technologies and spread financial risk.

Upsides

Denali's $500 million financing strengthens its financial position for pipeline advancement.

Partnership with Biogen could accelerate Parkinson's treatment development.

Focus on blood-brain barrier technology shows promise in treating lysosomal storage diseases.

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