Sr. Research Scientist, Non-Clinical Safety & Toxicology at Elanco
Indianapolis, Indiana, USA -
Full Time


Start Date

Immediate

Expiry Date

08 Oct, 25

Salary

0.0

Posted On

09 Jul, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Creativity, Drug Development, Literature, English, Immunology, Chemistry, Veterinary Medicine, Communication Skills, Toxicology, Monoclonal Antibodies, Management Skills, Biologics, Dermatology, Biology

Industry

Pharmaceuticals

Description

WHAT YOU NEED TO SUCCEED (MINIMUM QUALIFICATIONS):

  • Education: DVM and/or PhD (preferred) in toxicology or another relevant biomedical science discipline (e.g., veterinary medicine, biology, chemistry) with at least 5 years of industry experience in non-clinical safety, or a Master’s degree with at least 7 years of relevant experience.
  • Experience: Demonstrated ability to apply toxicology and risk assessment principles aligned with global regulations and guidance. Experience in non-clinical veterinary drug development, including target safety assessments, in silico predictions, and safety evaluations throughout product life cycles. Strong background in large molecule, biologics, vaccine, and antibody development, as well as using in vitro/in vivo data and literature to support product development and registration.
  • Top 2 skills: A strong, collaborative team-player with expertise in toxicology and immunology with strong risk assessment capabilities. Highly skilled in cross-functional collaboration, regulatory strategy, and effective communication of complex scientific concepts.

WHAT WILL GIVE YOU A COMPETITIVE EDGE (PREFERRED QUALIFICATIONS):

  • Board certification as a toxicologist (ERT, DABT, or equivalent).
  • Immunological background, especially related to monoclonal antibodies and emerging platform technologies for indications like dermatology or pain.
  • Deep understanding of US, European, and international veterinary drug development, as well as agribusiness practices for companion and farm animals.
  • Strong working knowledge of GLP regulations and experience with in silico toxicity prediction tools.
  • Ability to manage complex projects independently, with strong organizational and time management skills.
  • Excellent written and verbal communication skills in English.
Responsibilities

YOUR ROLE: SENIOR RESEARCH SCIENTIST, NON-CLINICAL SAFETY & TOXICOLOGY

We are seeking an experienced non-clinical toxicology / safety scientist to join the Global Non-Clinical Development team in Global Clinical Development. As the Senior Research Scientist, Non-Clinical Safety & Toxicology you will be responsible for, or will assist with, human (user & consumer) safety and target animal safety program strategy and execution at all phases of global veterinary pharmaceutical drug/product and feed additive research and development, product safety assessments, and support for marketed products.
This role applies toxicology and immunology expertise to assess safety risks across the full product lifecycle, from early development through commercialization. Responsibilities include evaluating potential safety concerns related to product design, manufacturing changes, deviations, or consumer complaints that could impact animal safety or end-user health. The role involves preparing Product Safety Assessments (PSAs) for products in development, production, or on the market, and compiling medical and toxicological data to assess potential health risks for consumers and end users.

YOUR RESPONSIBILITIES:

  • Independently design, organize, monitor, report, and resolve issues related to outsourced in vitro and in vivo safety/toxicology studies, utilizing external CROs and/or consultants as needed. These studies may involve typical rodent and non-rodent species. Target animal safety evaluations may include companion animals (dogs and cats) as well as food-producing animals (e.g., cattle, pigs, chickens).
  • Conduct literature reviews and author expert reports, position papers, safety and hazard/risk assessments, and other strategic scientific, technical, or medical evaluations to address safety considerations for veterinary drugs (small molecules and biologics), feed additives, excipients, E&L substances, impurities, or other chemicals.
  • Provide internal expert guidance, including expert statements, health-based exposure limits (e.g., PDEs, OELs), and target safety assessments.
  • Engage with regulatory agencies to address safety concerns for both products in development and marketed products, including preparing and submitting documentation and delivering formal presentations.
  • Collaborate closely with colleagues in Manufacturing, Quality, Human Food Safety, ADME/PK, and Environmental Safety to accomplish multidisciplinary non-clinical objectives for projects and products.
  • Proactively participate in global, cross-functional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing) within a matrix organization to drive project success.
  • Maintain technical and professional expertise by staying current with scientific developments and sharing relevant insights and best practices within the organization.

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

  • Multiple relocation packages
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
  • 8-week parental leave
  • 9 Employee Resource Groups
  • Annual bonus offering
  • Flexible work arrangements
  • Up to 6% 401K matchin
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