Director - Biological Pharmacokinetics

Vacancies

Director - Biological Pharmacokinetics

Job Introduction

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra!

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Our values are embedded within our culture and thrive within our family of almost 3000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

Invetx Inc., a Dechra division, is a veterinary biotechnology company based in the USA that is engaged in the discovery and development of novel therapeutic proteins for the treatment of important diseases in the veterinary species, initially focused on companion animals.

The Opportunity

We are seeking a highly experienced and innovative Director to lead pharmacokinetic (PK) strategy and execution for monoclonal antibody (mAb) therapeutics in the animal health sector . This role is pivotal in shaping the design, development, and regulatory strategy of biologics programs, with a focus on optimizing PK/PD profiles, assessing immunogenicity, and supporting regulatory submissions across multiple veterinary species.

Key Responsibilities

• Lead the design, execution, and interpretation of PK and PK/PD studies for monoclonal antibodies in preclinical and clinical development.
• Develop and implement translational strategies to bridge in vitro, in vivo, and clinical data.
• Serve as the PK subject matter expert on cross-functional project teams, collaborating with discovery, bioanalytical, toxicology, regulatory, and clinical teams.
• Design and oversee immunogenicity assessment strategies, including ADA (anti-drug antibody (ADA ) assay development and interpretation of immunogenicity data in the context of PK and efficacy.
• Develop and apply population PK, allometric scaling, and physiologically based PK (PBPK) models to support dose selection and label claims.
• Lead interactions with global regulatory authorities, including preparation and defense of PK and immunogenicity data in support of regulatory submissions (e.g., INADs, VMFs, dossiers).
• Manage external collaborations and CROs for study execution, data analysis, and bioanalytical method development.
• Stay abreast of scientific and regulatory advances in biologics PK, immunogenicity, and veterinary drug development
• Study Execution & Data Quality: Timely completion of PK and immunogenicity studies with high-quality, regulatory-compliant data.
• Regulatory Milestones: Successful submission and approval of PK-related sections in regulatory filings in US, EU and International markets (e.g., NADA, MAA , etc.) with minimal queries.

Ideal Candidate:

• Cross-Functional Collaboration: Effective leadership and contribution to cross-functional teams, as measured by project milestones and stakeholder feedback.
• External Partnerships: Quality and efficiency of CRO and academic collaborations, including adherence to timelines and budgets.
• Extensive industry experience in pharmacokinetics, with at least 5 years focused on monoclonal antibodies or biologics.
• Deep understanding of immunoglobulin biology, FcRn-mediated recycling, and species-specific PK considerations.
• Demonstrated experience in animal health or translational PK across veterinary species
• Expertise in immunogenicity assessment and its impact on PK and therapeutic performance.
• Proficiency in modeling and simulation tools (e.g., Phoenix)
• PharmD or Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Biopharmaceutics, Immunology, or related field.

Desirable

• Experience with novel biologic modalities (e.g., bispecifics, antibody fragments, fusion proteins).
• Familiarity with regulatory expectations for immunogenicity in veterinary biologics.
• Experience with GLP principles and their application in non-clinical studies.
• DVM

Additional Information:

• Expected travel 20-25% (domestic and international)