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Vice President, Clinical Development

Chicago, IL

Posted: 08/12/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2392

Reporting to the SVP, Clinical Development, the Vice President of Clinical Development will Manage all aspects of clinical operations to support product development activities for a pharmaceutical and biologics company with potential sales in multiple countries.

RESPONSIBILITIES:
  • Build and lead the clinical department to meet the expanding needs of the product pipeline, including budgetary and managerial responsibility.
  • Provide support for regulatory submissions and participate in interactions with FDA, EMA and other regulatory agencies.
  • Participate on project teams, providing appropriate information on clinical issues and obtaining needed information to meet project requirements.
  • Maintain current knowledge base on existing and emerging regulations, standards and guidance documents applicable to clinical trials.
  • Develop and maintain strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects.
  • Provide leadership, direction and coordination of across functional areas to drive integrated delivery of clinical development programs and associated projects.
  • Create and monitor clinical development plans, budgets, and timelines, and update work plans as appropriate to meet changing needs and requirements.
  • Identify, qualify and manage relationships with clinical research organizations and other product development vendors, ensuring adherence to contractual obligations.
  • Ensure clinical trials are carried out in compliance to all appropriate SOPs, guidelines and standards in accordance with GCP regulations.
  • Facilitate development of study tools and appropriate systems for coordination of clinical trials and tracking of expenses, enrollment status and investigational supplies.
  • Plan and coordinate the effort to analyze and publish study results, including updating clinicaltrials.gov postings in compliance with regulations.
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.

REQUIREMENTS / QUALIFICATIONS:

 
  • Bachelor’ s Degree in biology, chemistry or relevant scientific discipline; advanced degree preferred.
  • Professional with 15+ years of hands on experience with increasing responsibility in Clinical Development and Clinical Operations, preferably with smaller companies in late stage development
  • Prior responsibility for pharmaceutical product clinical development functions
  • Significant hands on experience in a biopharmaceutical company, including clinical and commercial products.
  • Extensive knowledge of US FDA regulations and industry practices.
  • Ability to critically evaluate and troubleshoot complex problems is essential.
  • Strong hands on leadership and management skills.
  • Ability to effectively participate on multi-disciplinary teams.
  • Ability to absorb, digest and relate detailed scientific and regulatory information.
  • Well-organized and detailed oriented professional, with strong verbal and written communication skills.

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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