Description
Join our dynamic team as a key clinical driver in antiparasitics, where you will be at the forefront of new animal development projects, ensuring safety and efficacy in target species.
This role offers the opportunity to shape clinical study design, manage resources and budgets, and contribute to the maintenance and extension of our existing licensed products in parasitology. You will be instrumental in guiding projects from protocol to execution, and ultimately to final study report for submission to regulatory agencies, in both lab and field conditions.
Duties & Responsibilities
- In your new role, you will lead Clinical Teams as Clinical Project Lead and will support the development and implementation of the clinical strategy for efficacy and safety of antiparasitic product development (from start of development to post approval support).
- Furthermore, you will ensure that clinical projects have optimal strategy, efficient study design, evaluated according to state-of-the-art principles and are properly presented.
- You will de-risk projects, characterize the salient health risks and support optimization of formulations for safe and efficacious products and support local and international regulatory submissions, and the maintenance and growth of existing products.
- Moreover, you will be responsible for the presentation of clinical content to regulatory authorities as required and ensures compliance with all applicable regulatory and animal welfare principles.
- Finally, you will act as the clinical project representative in governance meetings and organizational bodies to align clinical plans with company strategies and support clinical site study activities.
Requirements
- DVM strongly preferred from an accredited institution with previous experience in antiparasitic product Development or PhD or Masters Degree from an accredited institution with experience in parasitology
- Knowledge of regulatory requirements (e.g. FDA, EMA) and compliance
- Solid understanding of claim structure of veterinary antiparasitic products
- Experience with planning, conducting, reporting, analyzing and interpreting of clinical studies
- Previous experience with clinical laboratory and/or field studies (GxP and non-GxP) is a plus
- Clinical veterinary practice experience is a plus to support site study activities
- Team player with excellent communicational skillset to effectively work in an international and cross-functional matrix environment
Desired Skills, Experience and Abilities
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.