Sr. Manager, Clinical Affairs


Job ID:

6399

Company:

Job Location:

Fort Worth, TX


Job Requirements

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.


Personal Attributes



  • 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


Job Description

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. 


Essential Functions


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.


Industry:

Industry

Type:

Research & Development

Earnings:

$100,000 or more

Minimum Years Experience:

6 to 10

Travel:

0 to 25%

Minimum Degree:

DVM / PhD

# of Openings:

1

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