Senior Scientist

PRINCIPAL DUTIES & RESPONSIBILITIES:
The primary responsibility of this position is to provide strategic preclinical safety expertise and representation for clinical development programs from IND through post-marketing, and includes the following job duties:
• Represent Preclinical Safety on development program teams and contribute to the program team’s goals and deliverables.
• Serve as preclinical Safety Subteam Leader for their assigned programs.
• Ensure that the preclinical safety plan for the program is aligned with the clinical development plan and program objectives.
• Apply in-depth intellectual and technical expertise in toxicology and drug development to the assigned programs.
• Develop appropriate preclinical safety plans that are tailored to the therapeutic modality (e.g., small molecule, biologic, antisense oligonucleotide, or gene therapy).
• Apply knowledge of applicable regulatory guidelines (ICH, FDA, GLP) to the development of testing strategies and design of appropriate toxicology studies.
• Collaborate with other functional groups (study management, pathology, clinical, regulatory, research, translational sciences, DMPK, clinical safety, CMC, etc.) on program-related tasks and objectives.
• 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 and registration of biopharmaceuticals. This may include safety assessment of novel device and delivery systems.
• Able to absorb and synthesize a broad range of data from toxicology, pharmacology, and PK/ADME studies to complete the 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 safety function at country-specific regulatory meetings for their programs.
• Serve as a subject matter expert within their field of sub-specialization to provide input on other programs and studies, including external partnerships and due diligence reviews for in licensing and business development opportunities.
• May lead or participate in Biogen subcommittees for process improvement / modernization, as required.
• May represent Biogen on external scientific committees and industry working groups in the areas of drug development and regulatory toxicology.
• Provides mentorship to less experienced toxicologists and scientists within and outside of the Preclinical Safety Department
• Depending on level of interest, experience and skills, may supervise other toxicologists or Preclinical Safety scientists within the department

QUALIFICATIONS

• 7 - 9 years of combined toxicology and drug development experience in a biopharmaceutical setting.
• Toxicology board certification preferred.
• Working knowledge and experience in various phases of research and development for biop

The primary responsibility of this position is to provide strategic preclinical safety expertise and representation for clinical development programs from IND through post-marketing.