Senior Scientist, Non-Clinical Studies Manager
About the role
Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high-quality products exclusively for veterinarians worldwide. The Senior Scientist, Non-Clinical Studies Manager provides scientific and operational oversight of outsourced nonclinical/laboratory studies (PK, Safety, Efficacy) supporting drug discovery and development across Dechra Research & Development programs. This role acts as the primary sponsor representative for studies conducted at contract research organizations (CROs), ensuring studies are designed, executed, documented, and reported in compliance with applicable regulatory requirements, Good Laboratory Practice (GLP) regulations, and company standards.
The Senior Scientist partners closely with Safety Technical Leads and Efficacy Technical Leads, contributing to study design, data interpretation, and decision-making.
Responsibilities
- Non-Clinical Study Leadership & Execution
- Lead planning, setup, monitoring, execution, and reporting of non-clinical studies.
- Translate study objectives into executable study designs and operational plans.
- Communicate study status, risks, and outcomes clearly.
- Ensure timely escalation and resolution of issues.
- CRO & Test Facility Management
- Identify and select appropriate test facilities and supporting laboratories.
- Manage study budgets, purchase orders, contracts and invoicing.
- Manage CROs in planning, conduct, and reporting of studies.
- Maintain strong working relationships with external partners.
- Coordinate audits and ensure compliance of test facilities.
- Study Design & Scientific Contribution
- Support design of non-clinical studies in collaboration with the Safety or Efficacy Technical Lead.
- Monitor study conduct to ensure adherence to approved protocols, contracts, timelines, budgets, and quality expectations.
- Review raw data and final study reports to ensure accuracy, quality, and scientific integrity.
- Ensure study outputs meet regulatory expectations and support decision-making.
- Coordinate study drug acquisition, shipment, and delivery to test facilities in collaboration with the clinical supply lead.
- Ensure compliance with country-specific regulatory requirements.
- Ensure studies are conducted in compliance with SOPs, corporate policies, and regulatory requirements (e.g., GLP, Animal Welfare requirements).
- Ensure that study related documents and materials/samples are appropriately archived.
- Contribute to development of processes, tools, and technologies for non-clinical studies.
- Support implementation of new approaches to improve efficiency and quality.
- Bioanalytical & Method Development Oversight
- Coordinate with PK lead on the development and validation of bioanalytical methods.
- Ensure alignment between study design, sample analysis, and data requirements.
- Ensure bioanalytical data is incorporated into non-clinical study reports.
- Travel
- Ability and willingness to travel nationally and internationally as required.
Ideal Candidate
- Bachelor’s degree with extensive industry experience.
- Study Director experience in veterinary product development for GLP and non-GLP research studies.
- Experience managing CROs and external test facilities.
- Strong scientific and analytical skills.
- Experience with large and small molecules development.
- Experience across multiple study types (PK, safety, bioequivalence).