Associate Director

Proclinical is currently recruiting for an Associate Director for a leading global pharmaceutical company located in Southern San Francisco, CA. Successful candidate will demonstrate the ability to manage Phase I clinical trials and have extensive knowledge and understanding of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.

Job Responsibilities:

• Manage Phase 1 clinical trials within designated program budgets and timelines.
• Demonstrate excellence in complex project management and effectively manage multiple projects/priorities is required.
• Communicate scientific, medical, and organizational concepts to internal and external customers.
• Contribute to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents.
• Contribute to project team governance documents.
• Initiate continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams.
• Work independently to determine appropriate resources for resolution of complex problems.
• Solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Demonstrate understanding of pharmaceutical regulatory requirements and impact on
  development of clinical trials is required.

Skills and Requirements:

• 6+ years of experience with a BS/BA or MS.
• 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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