Manager, Development Projects

The Manager, Development Projects will design registration and product development operating plans, manage all clinical development aspects of pharmaceutical compounds including design of protocols for product registration studies in the EU and US; including preliminary safety, metabolism, pharmacokinetics and dose titration studies, first efficacy studies in laboratory conditions and pharmacokinetics studies with the final formulation, efficacy studies, safety studies and field trials. The Manager is responsible for negotiations on the clinical program with VMD, EMA, FDA and other relevant regulatory agencies, and will prepare parts III and IV (Safety and Efficacy Technical Sections) of new drug submissions for Veterinary Medicinal Products/New Animal Drugs. The Manager will provide clinical advice and trend analysis for pharmacovigilance reports to relevant regulatory authorities and will follow up on all research and development projects.

Qualifications include experience in research and regulatory veterinary medicine including interaction with governmental agencies, understanding of product development, protocols, Good Clinical Practice guidelines, research reports and dossier preparation.  D.V.M, V.M.D, B.V.Sc or equivalent is required.

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Bio Clinical Development Senior Scientist

The Biological Clinical Development Scientist will provide pivotal and non-pivotal clinical trial study design and implementation for cattle, swine and companion animal vaccine projects; including safety, field safety and efficacy.  The incumbent will serve as clinical core team member and the functional clinical leader on project teams from Research to Market Support vaccine projects, with an emphasis on pivotal studies in development to earn new product licenses and label claims. The incumbent determines the optimal and pragmatic clinical program for specific projects including all aspects of study methodology, design, conduct, data interpretation and reporting.  The incumbent communicates extensively with the International Project Leader, Regulatory Affairs, Veterinary Services, Data Management, Clinical Trial Supply, R&D Quality Assurance, Biostatistics, Sales and Marketing, contract research and field safety study personnel at study sites. The role is to ensure the conduct of field studies as well as internal studies at multiple locations and is assisted by Biological Clinical monitors and support staff as well as Veterinary Services for internal studies. The incumbent will serve a critical role in generating clinical safety and efficacy data and in expertly communicating conclusions in final reports of pivotal animal studies.

Qualifications include a Doctoral degree in Veterinary or related field, 1+ year of veterinary clinical practice, ability to travel up to 25% of the time, leadership experience, DVM with clinical experience, preferably with experience in vaccine development, functional knowledge of vaccine development is desired, excellent communication skills.

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Director / Manager of Quality Assurance Clinical Compliance

The incumbent is responsible for managing and conducting investigator site GCP audits; and providing GCP training internally and externally. We are looking for a highly driven individual who will thrive in a results-oriented, fast-paced environment.  The incumbent will perform the qualification or requalification of clinical Contract Research (CRO) service providers as directed. The incumbent will be responsible for assuring those suppliers/contractor/service providers associated with Contract Research activities are operating in compliance to GCPs, pertinent regulations and established industry standards. The incumbent will coordinate and perform external audits of Contract Research Organizations and other vendors/suppliers or assigned. The incumbent will assist in evaluations of quality systems employed by a supplier/contractor and when directed assist supplier/contractors in improvements. The incumbent will issue detailed written audit reports for vendor and investigatory site audits and will track and review all audit responses for complete corrective and preventative actions. The incumbent will contribute to the preparation and revision of standard operating procedures related to research and development, will conduct Investigator Site GCP Audits for selected clinical studies and investigator sites to assure Clinical Research Investigators are operating in conformance to GCPs, FDA regulations, ICH Guidelines and established standards.

Qualifications include Bachelor’s Degree in a scientific discipline, at least 7 years of experience in a regulated pharmaceutical environment, a minimum of 5 years of GPC auditing or clinical research monitoring experience, a comprehensive understanding of GCP, GMP and GLP FDA and ICH regulations. Strong interpersonal, teamwork, organizational and workload planning skills are required, along with the ability to travel up to 25%.

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General Manager / Plant Manager

General Manager/Plant Manager for Animal Health Pharmaceutical Manufacturing Plant- We are searching for a senior operations manager to provide top leadership for the day to day running of the plant.

Qualifications include animal health or human pharmaceutical background and experience working in a regulatory environment. The successful candidate will be experienced at negotiating supply contracts and customer relationships and will have the ability to grow revenue. We are searching for someone with strong values, integrity and leadership skills. The incumbent will work with support services such as Finance, IT, HR and HSE and will need to have operational and general management experience and have a proven track record in growing a business.

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Chief Pathologist

The incumbent will have overall responsibility for the autonomic pathology department including managing all pathologists and histology tech, scheduling staff, recruiting, hiring and training additional staff.  The incumbent will provide clients with diagnostic evaluation and consultation in the area of anatomic pathology/histopathology, including both microscopic and gross evaluation of surgical biopsy specimens.  Additionally, the incumbent will consult with clients regarding interpretation of pathology reports and responding to client inquiries; as well as consulting with and assisting other pathologists, both internal and external, on difficult cases or when his/her expertise is of relevance.

Qualifications include a DVM or equivalent degree, a minimum of 3 years of residency training in anatomic pathology, and board certification by the American college of Veterinary Pathologists (or equivalent certifying organization).  A minimum of 5 years’ experience in a veterinary clinical laboratory preferably managing the department or other management experience.

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Associate Director – Swine Bio R&D

The Associate Director will provide technical leadership on direction of projects and applications of the appropriate technical methods and application toward product licensure and/or research efforts. The Associate Director will contribute to the discovery, development and delivery of products for patients and customers.

Technical expertise will include PCR, Western Blots, SDS Page, Cell Culture, animal models (preferably in Swine), cloning, bioreactors, and protein expression and purification. The Associate Director will coordinate and facilitate communications, interactions and technology transfer between R&D and other teams (Assay, BioProcess, Clinical, Regulatory) with emphasis on moving research projects into development and efficient development of projects toward product licensure and commercial sale.

The Associate Director will network across the industry and with university and governmental agencies and will serve as the point of contact with R&D and the sales and marketing team and will ensure the technical quality and supervision of R&D activities as well as compliance and regulatory acceptance at the USDA and EU levels.

Qualifications include a proven track record in project management and product licensure, 4+ years of Leadership experience, the ability to assess, assemble and coordinate technical efforts into an effective plan focused on product development and registration. The incumbent needs to  understand swine diseases and production and their relevance to vaccine development. The successful candidate will have a Doctoral degree with a Veterinary focus and/or training in Biology. It is preferred that the successful candidate have experience in microbiology, virology or a clinical science with experience and relationships within the Animal Health Industry and academia with swine research leaders.

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Director of CMC

This is a virtual role.  The incumbent will be responsible for ensuring the investigational and new animal drugs are fully compliant with all FDA requirements for CMC. The incumbent will provide oversight and support for all pre- and post-approval CMC submissions to the FDA. The incumbent will establish and lead external CMC business relationships in support of development and manufacturing programs.  Working within a heavily cross-functional environment, the incumbent will interact directly with the FDA’s Center for Veterinary Medicine’s Division of Chemistry and Manufacturing Technologies, manage and supervise a cadre of CMC consultants, establish sourcing strategies, orchestrate due diligence efforts, negotiate contracts, and provide management oversight to outsourcing activities on behalf of the client business units within the organization.

 

Qualifications include a degree in chemistry/life sciences/engineering/pharmaceutical sciences required; advanced degree in chemistry/life sciences/engineering/pharmaceuticals sciences preferred.  10 years of experience in pharmaceutical industry or the Food and Drug Administration reviewing CMC submissions as well as experience working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, practices, and statues.  Knowledge of FD&C Act, 21 CFR, and FDA guidance pertaining to CMC is required.  Strong knowledge of pharmaceutical manufacturing operations, product and process development.

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Director of Development

The incumbent will lead one or more drug development programs and be responsible for all drug development activities from proof-of-concept studies through regulatory approval.  The incumbent will direct pre-clinical and clinical studies, cooperate with contract research organizations, coordinate formulation development and manufacturing activities as well as manage the overall development projects.  Additionally, the incumbent will  partner with and coordinate R&D management and staff to identify and evaluate capabilities of contract research organizations (CROs) who will be supporting development activities. The incumbent will represent the company at FDA’s Center for Veterinary Medicine and work with consultants and CROs on regulatory strategies as well as draft and submit required regulatory documents.  The incumbent will develop and present summaries of scientific data to management, Board of Directors, and at scientific meetings as directed by management. 

Qualifications include a minimum of 5 years in animal health drug development or equivalent with project management experience is desired, with a working knowledge of managing complex projects in a regulated environment.  DVM/VMD is preferred but a MS or PhD in life sciences with significant animal health drug development experience or equivalent will be considered.  The successful candidate will be able to work effectively in a high-energy, new company environment and be a flexible thinker, adaptive to emerging issues, comfortable working without defined boundaries or processes.

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Head of Research

The Head of Research is responsible for analyzing literature and FDA documents and designing clinical strategy for a new product.  The incumbent will keep up to date in the pertinent therapeutic areas as well as writing protocols, consent forms, and helping to design data collection forms.  Key responsibilities may include assessing the risk: benefit of any given product under development or being considered for development; assist in recruiting veterinarian investigators to participate in clinical trials as well as review electronic database of clinical data during a clinical trial to screen for safety issues, adverse events, serious adverse events, and communicating such to the team and to the FDA.  The incumbent will set up and run pharmacokinetic studies with outside contract organizations, including locating analytical lab and in-life study site, and managing the study from start to completion.  The incumbent will make scientific presentations to investigators, staff members, FDA, USDA, and at medical conferences as required.  Additionally, the incumbent will assist clinical staff to clean database and answer medical questions during this process and communicate with investigators regarding enrollment issues, adverse events, and other problems that may arise; as well as work with academic investigators at veterinary schools to undertake clinical laboratory work in dogs, cats, and horses. 

Qualifications include a Doctor of Veterinary Medicine degree and 3-5 years of pharmaceutical research and development experience. Specialty training is a plus. 30% travel is required.

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Director of Product Development

Director of Product Development (virtual role-can be based anywhere in the US)

We are looking for a small molecule CMC person.

The incumbent will oversee Contract Manufacturing Organizations, including formulation (e.g., solid oral, injectables, controlled release, topical), will develop quality agreements, handle batch record review, analytical methods review and preparation of regulatory documentation for NADAs, etc. Qualifications include hands-on experience working in a manufacturing plant, e.g. at a CMO, experience managing timelines and developing back-up plans, ability to develop process and improve upon existing process and willingness to travel about 50%. Formulation development experience is a plus and FDA/CVM audit experience is a plus.

To learn more and/or apply for this exciting opportunity, please  Apply Now.