Sr. Manager, Clinical Affairs
Fort Worth, TX
Formal Education and Certification
- Doctor of Veterinary Medicine degree is required
- DVM/Ph.D. duel-degrees is highly preferred
Knowledge and Experience
- A minimum of 5 years experience in pharmaceutical, clinical study management originating from the animal healthcare sector – with a high preference for a background from a sophisticated, brand-name player in the industry.
- Demonstrated knowledge of and hands-on experience in managing and conducting field safety and efficacy programs for animal health.
- Working knowledge to conduct laboratory studies for safety, toxicology, PK-PD and bioequivalence.
- Well established understanding of pharmaceutical regulations - in particular Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and product registration.
- Documented experience in managing third-party vendors (CMOs and CROs). Examples will be requested.
- Clinical study budgetary management which aligns with the endorsed project plan and supports efficient program execution – is expected.
- Ability to manage and work effectively inside a global enterprise – with the savvy to appreciate differences in cultures and standards (e.g., Europe vs. U.S.).
- A broad understanding and a natural curiosity of current and future trends within the field of animal health as it pertains to therapeutic areas and related technological innovation.
- Ability to effectively communicate and work in collaboration with internal and external experts
- A self-starter with a strong work ethic and a results-oriented mentality.
- Must possess unquestioned integrity, ethics, and values.
- Excellent oral and written communication skills.
- High attention to detail.
- Ability to work independently, multi-task, adjust duties, and eager to work in a dynamic and diverse organization.
- Requires ability to influence others or gain acceptance in sensitive situations in order to insure compliance and quality.
- Ability to function independently in a multi-task environment, as well as part of a team
- Desire to serve
This position may work from the Fort Worth, Texas offices or from a remote location.
The Sr. Manager provides technical leadership for pre-clinical, toxicology and clinical activities being conducted for Vétoquinol animal health products. The successful candidate will oversee and coordinate multiple contract research organizations in pharmacokinetic-pharmacodynamic, safety and clinical activities for a portfolio of projects. Scientific leadership will be required from lead optimization to product approval and launch, supporting a pipeline of new veterinary drug products while working in a multi-disciplinary team environment.
Clinical Research Management
- Initiates and manages contracts, coordinating activities, and working with selected CROs for pre-clinical development work in areas such as safety, toxicology and pharmacokinetics
- Supports detailed project planning of clinical activities, working closely with the US development team and other cross functions.
- Designs and manages clinical studies through writing clinical monitoring plans in accordance with protocol requirements established by Vétoquinol R&D.
- Reviews and edits pre-clinical and clinical study reports; analysis and interpretation of data and coordination of the final study report and associated dossier filings for market approval.
- Monitors assigned clinical trials, as required, following company SOPs and in accordance with GLP, GCP, FDA regulations, and applicable international regulations concerning clinical trial activities; support/conduct quality audits as appropriate
- Fulfills development strategy and timelines as per project requirements in consultation with other cross functions and the CRO partner.
- Identifies and prepares study related documentation (protocols, consent documents, letters of agreement, confidentiality agreements, etc.).
- Identifies and evaluates CROs, finalizing agreements and scope of work in consultation with other cross functions including supply chain and legal.
General and Administrative
- Supports the corporate vision, mission and values.
- Communicates effectively with various management and operational departments.
- Complies with all OSHA safety requirements, work rules and regulations.
- Compiles and maintains all required paperwork, records, documents, etc.
- Follows systems and procedures outlined in company manuals.
- All other duties as requested by management.
Minimum Years Experience:
# of Openings:
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