FierceBiotech and FiercePharma Jobs
Senior Scientist / Toxicologist - Confidential
Nov 03
Location: Cambridge, MACategories: Scientist
Website:
Position Description
The successful candidate will design, manage, and interpret non-clinical studies; interact with CROs; prepare and defend non-clinical regulatory submissions and strategies; serve on Research and Development project teams; serve as a resource for due diligence teams; and manage departmental staff. Previous vaccine/biologic product development and project team experience at a pharmaceutical or biotechnology company is required.
Major Duties and Responsibilities:
• Develop regulatory toxicology strategies and oversight of externally- conducted GLP toxicology studies to support clinical development of novel vaccine and adjuvant candidates
• Use innovative approaches to help select lead candidate antigens and adjuvants for development
• Prepare intra- and extra-mural presentations, and publish (when possible)
• Write and review non-clinical sections of regulatory documents and presentations (pre-IND, IND/CTA, Investigator Brochures, Scientific Advice, BLA/MAA, VRBPAC)
• Represent Toxicology on Research and Development project teams
• Supervise other toxicologists
Requirements/Qualifications:
• 10+ years of relevant experience in the biotechnology/pharmaceutical industry (including >3 years in vaccines research and development)
• PhD or DVM with focus on Toxicology or a related field (cell biology, immunology, disease models)
• Board certification desired
Special Skills/Abilities:
• Experience in non-clinical safety assessment of vaccines and biologics
• High level of independence and excellent judgment
• Experience interacting with regulatory agencies
• Can lead, motivate, and develop staff
• Dedicated, candid, adaptable, self-motivated, and (compulsively) attentive to detail
• Ability to work independently and collaboratively on multi-disciplinary global teams
• Excellent writing, presentation, and interpersonal skills
How to Apply
Interested candidates, please contact:Stephanie Parks
508-359-8294
sparks@xavierassocaites.com
