Director, Clinical Development (9135) - Employment,career opportunity in USA

Job Title:  Director, Clinical Development (9135)
Location: - (Texas, South-West United States, USA)
Company: Ag 1 Source
Job Type: Full Time
Minimum Years Experience Required: 5
Salary: Starts at: $150,000.00 Up to: $225,000.00



Director, Clinical Development

This position contributes to our company's success by providing development of new products and on-going support for existing products (both regulated and non-regulated). This position also includes supervisory responsibilities.

Duties and Responsibilities Include:

    Establish comprehensive project plans (budget, staffing, consultants, CRO's, CMO's, and equipment needs)
    Strategize, plan, coordinate, and execute all activities necessary to support dossiers
    Report key project metrics to various functions and levels
    Effectively manage third party CRO's and CMO's to drive successful outcomes
    Provide pre-launch, technical support to various departments
    Effectively motivate team to drive successful outcomes
    Maintain good laboratory and clinical practices (GLP's, GCP's) quality control audits for Development Project studies on raw data and final reports
    Respond to requests by regulatory agencies and development review studies
    Maintain project master files and documents to audit
    Suggest new product candidates based on portfolio and market needs

Requirements:

    DVM (Required), PhD or MS in Science Curriculum along with supervisory experience
    Training/Experience in Project Management (PMP Strongly preferred)
    Working knowledge of CFR's relevant to FDA/CVM, and EPA; working knowledge of GLP's and GCP's
    Demonstrated mastery of technical writing skills
    Demonstrated effectiveness in all forms of communication

*Candidates must be eligible to work in the US as well as meet the qualifications listed above in order to be considered for the Director, Clinical Development job.


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