Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I
IV)
Responsible for oversight and strategic direction and implementation across projects
Initiates continuous efforts in reviewing and identifying best practices among study teams
Directs development of SOPs within department and participates in 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

12+ years of experience 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
Excellent verbal, written, interpersonal skills
Ability to lead multifunctional teams
Ability to manage staff and mentor junior staff
Ability to solve complex problems
Experience managing cross-functional teams or work groups as well as direct reports
Demonstrated understanding of pharmaceutical regulatory requirements and impact on clinical trial development
Experience with presentations before executive staff
Extensive experience in developing RFPs, selection of CROs/vendors, and management of external resources
Proven ability to effectively communicate scientific, medical, and organizational concepts

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off

Director, Clinical Operations

Key skills