Director, Clinical Operations

Descripción del trabajo

Specific Education & Experience Requirements:

• 12+ years of experience and a BS in a relevant scientific discipline.
• 12+ years of relevant experience and a MS degree.
• 14+ years of experience and an RN (2 or 3 year certificate)
• Prior experience leading and overseeing oncology clinical trials with a minimum of 5 years’ experience in the design and delivery of Phase 1 first in human (FIH) oncology clinical trials

Specific Job Responsibilities:

• Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and through the use of CROs or internal resources.
• Responsible for oversight and strategic direction and implementation across a number of projects to ensure clinical programs are conducted to meet project milestones and budgets through close partnership with parties involved both inside and outside of the company.
• Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams.
• Directs development of SOPs within department and participates in development of collaborative SOP development.
• May contribute to Clinical Study Reports, INDs, NDAs, and other clinical/regulatory/safety documents.
• Contributes to development of abstracts, presentations, and manuscripts.
• Manages study teams to ensure deployment of resources.
• Travels nationally and internationally as required.
• Represents the company at professional events and may present company clinical initiatives and findings at such events.
• Extensive clinical experience is required.
• Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff, and mentor junior staff is required.
• Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Must be able to successfully develop, implement, manage and complete complex clinical trials and manage vendor relations.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems.
• Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required.
• Experience managing cross-functional teams or work groups as well as direct reports.
• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required.
• Experience with presentations before executive staff.
• Extensive experience in developing RFPs, selection of CROs/vendors, and management of external resources is required.
• Demonstrated ability to manage international clinical trials within designated program budgets and timelines is required.
• Demonstrated ability to manage budgets.
• Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers.
• Ability to initiate, and lead departmental or interdepartmental strategic initiatives.

This role can be based at our site in Foster City, CA or Parsippany, NJ