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VP Clinical Development

Company: Advanced Clinical
Location: San Diego
Posted on: June 14, 2018

Job Description:

OVERVIEW

We are currently searching for a skilled professional to join a well-known clients team as Vice President of Clinical Development in San Diego, California. The VP of Clinical Development role will report to the Chief Medical Officer and provide strategic direction and technical leadership to the Clinical Development group. The ideal candidate will be responsible for the overall management and performance of department functions to develop and execute regulatory and Phase I-IV clinical trial strategy and design. Their work will have a direct impact on not just the organization but also on the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES


  • Prepare clinical portions of new Drug Applications and Biologics License Applications, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios
  • Serve as the clinical lead for advisory meetings
  • Establish and maintain relationships with alliance partners, external companies (such as CRO), investigators, and opinion leaders to optimize performance on clinical trial activities
  • Create manuscripts for technical journals and present at scientific meetings
  • Collaborate with Research and Development to provide input into design of preclinical trials to support drug products entering or in the clinic
  • Provide input to evaluate products for in licensing/out licensing
  • Participate in business development processes
  • Manage and be responsible for pharmacovigilance for clinical projects including review and reporting of SAEs with support from pharmacovigilance providers
  • Design protocol strategy and assist with development of regulatory and study documents
  • Analyze study level data, review patient narratives and report data driven decisions
  • Develop specific medical/protocol training for Clinical Research Associates (CRAs) and study team
  • Answer medical/safety questions and resolve medical/safety issues from sites, CRAs and study team
  • Interact with regulatory groups and internal auditing groups on a study level
  • Contribute to, review, and edit Clinical Study Reports (CSR)
  • Assist and lead development of scientific meeting abstracts and presentations including manuscripts


    EXPERIENCE


    • Minimum of 6+ years of experience required in relevant industry, clinical/medical research, or pharmaceuticals/devices
    • Minimum 4+ years of supervisory experience managing a clinical functional team required
    • Oncology experience required
    • Demonstrated experience of FDA/EMEA/Japan PMDA requirements, good clinical practices, and pharmaceutical clinical development in oncology
    • Leadership experience in drug approval
    • Analytical and strategic planning skills, with a track record of recruiting and/or out-sourcing high-performing clinical teams
    • Ability to travel domestically and internationally


      EDUCATION


      • MD required in a relevant scientific discipline


        To be a best-fit your strengths must include


        • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
        • Organized. Youre an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
        • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
        • Problem-Solvers. As an action-oriented self-starter, youre eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
        • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
        • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.


          About Advanced Clinical

          Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribunes Top Workplaces, Chicagos Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

          Regarding your application

          Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

          Keywords: Advanced Clinical, San Diego, VP Clinical Development, Healthcare, San Diego, California

          Click here to apply!

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