Advisor Veterinary Clinical Development
- Expired: over a month ago. Applications are no longer accepted.
Advisor, Veterinary Clinical Development
Global Lead, Product Development
Full time, exempt
Hybrid based out of Chadds Ford, PA or Research Triangle Park, NC or Remote
At knoell Animal Health, LLC, you are part of an international team of more than 45 Animal Health experts including specialists in pharmaceuticals, biologics, feed additives, toxicology, safety, chemistry, and clinical studies. We support manufacturers of animal health products with our extensive expertise at every point of the product life cycle. Our animal health experts support our clients in gaining access to global key markets including Europe, North & South America, and Asia.
The Advisor, Veterinary Clinical Development acts as the primary interface between the project team and the client. The Advisor is responsible for the overall conduct of projects under their management, including resource management, budget, and timelines.
This role requires strong knowledge of VICH GCP regulations and experience managing multi-site, pivotal clinical studies. As a member of the Clinical Development Team, this role is involved in the planning, conduct, and reporting of Veterinary Clinical Studies conducted in compliance with VICH Topic GL9 (GCP), Guideline on Good Clinical Practice: (CVMP/VICH/595/98 – Final, or CVM GFI #85 (VICH GL9) Good Clinical Practice).
- Provide strategic regulatory advice to clients regarding clinical development of veterinary biologics and pharmaceuticals. Evaluate existing safety and efficacy studies for regulatory compliance and perform gap analyses of existing data against regulatory expectations. Produce written development plans for clients, including timelines and costs associated with veterinary or biologics development.
- Manage projects involving the development of veterinary biologics or pharmaceuticals, including setting up projects within the knoell resource planning system.
- Compile proposals for projects and negotiate contracts with both clients and third parties.
- Monitor and track project time and pass-through costs budgets and have responsibility to approve third party invoices related to the project.
- Ensure the direction of team members selected for roles in the project by organizing and leading project meetings.
- Attend and organize client and third-party visits and meetings.
- Participate in VICH Good Clinical Practice (VICH GCP) veterinary clinical studies in the role of Monitor.
- Compile and peer-review Standard Operating Procedures, clinical study protocols and study reports, data collection sheets, general forms, and other associated documents using knoell Animal Health templates, according to appropriate guidelines and in accordance with training and competency.
- Conduct monitor visits at study sites (including commercial farms, veterinary practices, kennels, stables, laboratories, contract research organizations, etc.) to recruit, qualify and train study participants, review the performance of the study and verify the data collected.
- Compile monitor reports of visits to report on the progress of the study and obtain corrective actions as necessary.
- Review regulatory studies (performed in compliance with Good Laboratory Practice (GLP) or GCP or other applicable standards) conducted by third parties related to the development of veterinary biologics or pharmaceuticals, in the role of Sponsor Representative.
- Enter study data and/or company administrative data into spreadsheets and databases. Verify data when applicable by using established quality control techniques. Analyse data using simple functions, including statistical features, to prepare tables, graphs, charts and reports.
- Adhere to the following in all appropriate aspects of the position:
- Maintain documentation, records, data in general adherence to applicable standards, internal quality systems and policies of knoell Animal Health.
- Communicate with clients and other external bodies in line with company policy.
- Conduct other work suitable to abilities, training, experience and position, as requested. This may include administrative tasks and assistance to other Company personnel.
QUALIFICATIONS AND PREFERENCES
- Bachelor’s degree (or equivalent) required, preferably in animal science, biology, or related life science/medical fields
- Minimum of 5 years of clinical study experience in the animal health field
- Experience with GCP and/or GLP studies
- Ability to travel to study sites or client meetings in the US up to 25% of time
- Experience working in private veterinary practice is a plus
- Strong communication and resource-management skills in a client-driven environment
- Ability to multitask and prioritize to meet deadlines in timely manner
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization and the client’s organization if applicable
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to work independently with limited oversight
- Ability to identify and solve problems in a strategic manner
- Ability to be proactive and anticipate the dynamic needs of clinical studies
knoell is one of the leading global service providers for worldwide registration and regulatory compliance. With a global network of more than 600 employees, we support clients in the registration of crop protection and crop nutrition products, chemicals, biocides, animal health products or medical devices. Over 20 years of experience and with a constant focus on understanding our clients and their needs, we deliver the best possible regulatory and scientific solutions for them. People are at the heart of our family-owned business and our values guide the way to our success. Team spirit and mutual support are very important to us. Our culture is characterized by strong international cooperation, can-do attitude, a focus on quality and growth mindset.
knoell offers competitive compensation and benefits package, including medical, dental, vision, life, disability, 401(k) with company match, and tuition reimbursement.
We are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
knoell is a drug-free workplace. As a condition of employment, new hires may be required to pass a pre-employment drug test.
knoell complies with federal and state disability laws and makes reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, please contact our Recruiting department at email@example.com.
The above information on this description has been designed to indicate the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job. While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time.
knoell Animal Health LLC
AddressChadds Ford, PA
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