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Toxicology Lead, West Coast Hub

8-12 years
$168,000 – $231,000
10 April 3, 2025
Job Description
Job Type: Full Time Education: Ph.D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 


Toxicology Lead – Biogen

Employer: Biogen
Location: South San Francisco, CA
Region: US
Department: Research & Development
Job Type: Full-time


Job Description

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.

Key Responsibilities

Nonclinical & Toxicology Strategy

  • 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.

Regulatory Compliance & Collaboration

  • 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.

Cross-functional Leadership & Data Integration

  • 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.


Qualifications

Education & Experience

  • 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.

Skills & Competencies

  • 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.


Compensation & Benefits

  • 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


Why Biogen?

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.


Apply Now

Join Biogen and be a leader in transforming drug development. Apply today!