Senior Animal Health Product Development Consultant
Listed on 2026-06-04
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Research/Development
Research Scientist, Clinical Research -
Healthcare
Clinical Research
Senior Animal Health Product Development Consultant
Product Life Group (PLG), a leading international pharmaceutical consulting organization, is looking for an experienced Senior Animal Health Product Development Consultant to support the scientific and clinical justification strategy for our animal health pipeline. This role sits at the intersection of preclinical pharmacology and bioequivalence science to provide expert clinical rationale required to support biowaiver within a team‑driven environment. The role will manage the product development requirements (pre‑clinical and clinical) and will manage development projects from initial conversations to live‑phase study activities to final study report.
The ideal candidate is a DVM, PhD pharmacologist, or DVM/PhD dual‑degree holder who understands target species physiology, PK/PD relationships across veterinary species, and what CVM expects when a sponsor argues that an in vivo bioequivalence study is unnecessary.
Role and Responsibilities- Lead the clinical and scientific justification strategy for biowaiver requests submitted under ANADA phased review, including written rationale on why an in vivo BE study is not necessary for specific product categories.
- Evaluate product candidates for biowaiver eligibility based on route of administration, dosage form, solubility, target species GI physiology, and CVM guidance.
- Author or co‑author the clinical justification sections of ANADA submissions, including physicochemical comparisons (Q1/Q2/Q3), dissolution data interpretation, and species‑specific PK arguments.
- Design and oversee dissolution studies, solubility studies, and in vitro BE studies conducted at CROs as needed to support biowaiver applications.
- Serve as the primary scientific contact with FDA/CVM on bioequivalence and biowaiver matters, including pre‑submission meetings.
- Provide veterinary/pharmacological input to the broader R&D and regulatory teams on target species differences (dog, cat, horse, cattle, swine) affecting drug absorption and disposition.
- Maintain awareness of evolving CVM guidance, VICH guidelines, and ICH harmonization relevant to veterinary bioequivalence.
- DVM, PhD in pharmacology/pharmaceutical sciences, or DVM/PhD; board certification in veterinary clinical pharmacology (ACVCP) a strong plus.
- 7+ years of experience in veterinary pharmaceutical R&D, regulatory affairs, or preclinical science in an industry setting.
- Working knowledge of FDA/CVM ANADA and NADA approval pathways, including phased review and the bioequivalence technical section.
- Demonstrated understanding of the biowaiver framework for veterinary products: eligible product categories, Q1/Q2/Q3 comparisons, solubility criteria, and the role of clinical justification.
- Strong grasp of PK/PD principles as applied to veterinary species, including species‑specific differences in GI physiology relevant to oral drug absorption.
- Prior interaction with FDA/CVM reviewers on bioequivalence or biowaiver questions.
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