Clinical Director Jobs

About The Position

Requirements

• Deep understanding of clinical trial processes
• Regulatory compliance (GCP, FDA, ICH)
• Ability to lead cross-functional teams
• In-depth understanding of managing early phase oncology trials at a sponsor biotech
• Work authorization: United States (Required)

Responsibilities

• Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials.
• Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.
• Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others.
• Ensure deliverables are met on time, within budget, and to quality standards.
• Manage, mentor, and support direct reports, fostering professional development and team performance.
• Participate in site selection, feasibility assessments, and initiation visits.
• Build strong relationships with investigators and site staff to support efficient enrollment and high-quality data collection.
• Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals.
• Review monitoring reports and ensure timely resolution of issues.
• Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented.
• Conduct ongoing data reviews and support data cleaning activities.
• Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF).
• Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders.
• Work closely with internal stakeholders including Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs.
• Provide guidance and mentorship to junior team members and cross-functional colleagues.
• Share best practices and contribute to continuous process improvement.
• Prepare and deliver study updates, metrics, and presentations to senior leadership.
• Represent Clinical Operations in internal and external meetings.
• Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance.
• Willingness to travel up to 15% for site visits, vendor meetings, and conferences.
• Other activities as assigned.

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with flat non-elective employer contribution
• Comprehensive medical insurance with 90-100% employer-paid premiums
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
• Unlimited PTO
• Generous holiday schedule; includes summer and winter company shutdown
• Relocation assistance