Toxicology Lead, West Coast Hub

Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.About This Role:The Toxicology Lead, West Coast Hub role will report to the Head of Clinical Pharmacology, WCH with matrixed reporting to the Head of Discovery Toxicology and/or the Head of Development Toxicology.  The primary responsibilities of this position are to provide strategic nonclinical safety expertise and representation for clinical development programs from discovery through post-marketing, and includes the following job duties:Apply a broad understanding of toxicology, pharmacology, drug metabolism/pharmacokinetics (DMPK) and regulatory sciences to design all types of toxicology studies required to support clinical development, regulatory strategies and registration of biopharmaceuticals. This may include safety assessment of novel device and delivery systems.Apply in-depth intellectual and technical expertise in toxicology and drug development to the assigned programs.Develop appropriate preclinical and nonclinical safety testing strategies that are tailored to the therapeutic modality (e.g., small molecule, biologic), including design and oversight of in vitro and in vivo toxicology studies.Develop risk assessments to inform key decision points and progression of drug candidates through stages of development.Ensure that the preclinical/nonclinical safety plan for their programs is aligned with the clinical development plan and program objectives.Apply knowledge of applicable regulatory guidelines (ICH, FDA, GLP) to the development of testing strategies and design of appropriate toxicology studies.Represent Preclinical and/or Nonclinical Safety on program teams and contribute to the program team’s goals and deliverables. Collaborate effectively with other functional groups (study management, pathology, clinical, regulatory, research, DMPK, biomarkers, clinical pharmacology, clinical safety, CMC, etc.) on program-related tasks and objectives.Be able to absorb and synthesize a broad range of data from toxicology, pharmacology, and PK/ADME studies to complete the nonclinical risk assessment and establish safe use conditions in humans for novel therapies.Prepare high quality regulatory documents for submission to support clinical development and marketing authorizations globally.Represent the preclinical and/or nonclinical safety function at country-specific regulatory meetings for their programs.