Associate Director

Varite Foster City , CA 94404

Posted 2 months ago

Associate Director

Req I D

GS-7220

Rate

Primary Skills

Description

Associate Director

Specific Responsibilities and Skills for Position:

  • Demonstrated ability to manage Phase 1 clinical trials within designated program budgets and timelines is required

  • Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required

  • Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers

  • Contributes to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents

  • May contribute to project team governance documents

  • Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams

  • Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems

  • Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines

  • Excellent verbal, written, interpersonal skills and ability to lead multifunctional teams

manage staff and mentor junior staff is required

  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on

development of clinical trials is required

Knowledge:

  • Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams,

ability to manage staff and mentor junior staff is required

  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on

development of clinical trials is required

  • Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local

regulations), ICH Guidelines, and GCPs governing the conduct of clinical trials and noninterventional

studies

  • Proven ability for successful study implementation and completion

  • Ability to motivate teams and drive performance

Experience and Skills:

  • At least 8+ years of experience and a BS or BA in a relevant scientific discipline

  • At least 8+ years of relevant experience and a MS degree

  • At least 8+ years of experience and an RN (2 or 3 year certificate)

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Associate Director

Varite