Employer: Biogen
Location: South San Francisco, CA
Region: US
Department: Research & Development
Job Type: Full-time
Biogen’s West Coast Hub (WCH) is focused on developing novel targeted therapies for patients with severe immune-mediated diseases. The Toxicology Lead will report to the Head of Clinical Pharmacology, WCH, with a matrixed reporting structure to the Head of Discovery Toxicology and/or Head of Development Toxicology.
This role provides strategic nonclinical safety expertise from discovery through post-marketing, ensuring the successful development of biopharmaceuticals and novel drug delivery systems.
Design toxicology studies to support clinical development, regulatory strategies, and drug registration.
Apply expertise in toxicology, pharmacology, drug metabolism (DMPK), and regulatory sciences.
Develop preclinical and nonclinical safety testing strategies tailored to different therapeutic modalities (small molecules, biologics, etc.).
Ensure alignment of preclinical safety plans with clinical development objectives.
Conduct risk assessments to inform key drug development decisions.
Ensure compliance with ICH, FDA, and GLP regulatory guidelines in toxicology testing strategies.
Represent Preclinical/Nonclinical Safety in cross-functional program teams.
Prepare regulatory documents to support clinical development and marketing authorizations globally.
Engage with regulatory agencies, including participation in country-specific regulatory meetings.
Collaborate with teams across study management, pathology, clinical, DMPK, biomarkers, pharmacology, safety, and regulatory.
Analyze toxicology, pharmacology, and PK/ADME data to conduct nonclinical risk assessments.
Lead and mentor junior toxicologists and nonclinical safety scientists.
Ph.D. in Toxicology, Pharmacology, or a related field.
8-12 years of toxicology and drug development experience in biopharmaceuticals.
Toxicology board certification preferred.
Experience in all phases of drug research & development.
Expertise in GLP and non-GLP in vitro and in vivo toxicology study design.
Strong understanding of regulatory guidelines (ICH, FDA, GLP) and regulatory agency interactions.
Proven leadership and cross-functional collaboration skills.
Excellent communication, technical writing, and scientific dialogue skills.
Ability to mentor and develop junior toxicologists.
Base Salary Range: $168,000 – $231,000 (Determined based on experience, skills, location, and internal equity).
Short-term and long-term incentives, including cash bonuses and equity incentives.
Comprehensive Benefits Package, including:
Medical, Dental, Vision, & Life Insurance
Fitness & Wellness Programs (incl. reimbursement)
Short- & Long-Term Disability Insurance
15+ days of vacation + year-end shutdown (Dec 26-31)
12+ company holidays + 3 personal days
80 hours of sick leave per year
Paid Maternity & Parental Leave
401(k) program with company matching
Employee stock purchase plan
Tuition reimbursement up to $10,000 per year
Employee Resource Groups participation
At Biogen, we combine global impact with an inclusive, innovative culture. As a mid-sized biotechnology company, we offer the stability and resources of a well-established business while ensuring that individual contributions make a significant impact.
We foster:
✔ Learning, growth, and career development opportunities
✔ A commitment to diversity, equity, and inclusion (DE&I)
✔ A collaborative environment where every role plays a vital part in delivering life-changing medicines
Our Values: Caring Deeply
Achieving Excellence
Changing Lives
Equal Opportunity Employer: Biogen provides equal employment opportunities regardless of race, gender, age, disability, or any protected status.
Join Biogen and be a leader in transforming drug development. Apply today!
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