Director Clinical Development

HCA   •  

Nashville, TN

Industry: Healthcare

  •  

5 - 7 years

Posted 34 days ago

Duties and Responsibilities:Duties include but are not limited to:

  • Lead clinical development strategies for client programs (compound/portfolio of clinical studies) as appropriate
  • Accountable for all program deliverables and client relationship
  • Key point of contact, point of issue escalation and interface with client company(s) to lead relationship management, clinical strategy support, and if applicable presenting clinical development strategies to governing bodies and oversight committees
  • Interface with the Sarah Cannon Physician Leadership, Scientific Leadership and Development Innovations Leadership Team to coordinate the strategic planning for client clinical programs and to support operational implementation and delivery of the associated clinical studies.
  • Represent Sarah Cannon to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively
  • Oversee interdisciplinary clinical research teams (matrix model)
  • Oversight for development and implementation of program plans
  • Ensure studies are conducted in compliance with GCP, relevant SOPs and regulatory requirements
  • Responsible for program management components of inspection readiness for all aspects of the program conduct
  • Responsible for the financial and operational health of all studies within the program or portfolio
  • Proactively identify and manage issues
  • Lead the development of contingency planning and risk mitigation strategies to ensure successful delivery of program goals program management reports for clients and management
  • Implement resource strategies to achieve program goals
  • Participate in bid defense meetings where presented as potential lead for program activities
  • Lead operational input to proposal development and pricing including proposed program strategy
  • Support operational excellence by identifying best practices, actively participating in Project Review Meetings, and by making recommendations to senior management
  • Works on new initiatives and special projects as directed by President, Sarah Cannon Development Innovations / Sr. Director, Clinical Development



Qualifications

Minimum Qualifications Education: Minimum Required: Bachelor's Degree (4 Year Degree) Preferred: Master's Degree Experience:

Minimum Required:

  • At least 5-7 years of experience in a CRO/pharma/biotech organization; pharmaceutical experience is most preferred
  • At least 5 years of oncology clinical research experience
  • Experience working as a Director of Development/Head of Clinical Development; or experience working in clinical development strategy for a pharma company
  • Experience working with clinical strategy support with various sponsor companies and senior leadership
  • Excellent presentation skills to include oral and written communication skills

Preferred:

  • 5-7 years or more of experience working in a pharmaceutical organization
  • Bid Defense experience
  • Clinical Project Management experience
  • Prior experience working as a Director of Clinical Development at a pharma company

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