Director/Sr. Director

Job Summary:

The Director/Sr. Director - Clinical Operations is responsible for providing leadership to assigned Clinical Program(s) and for ensuring studies (Phase I-IV) within a program are being managed in accordance with the company’s overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a Clinical Program are in compliance with the company’s procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Director/Sr. Director - Clinical Operations is a member of the Leadership Team within the Clinical Operations Department and as such, this person will play a key role in contributing to the culture of the department, building strong relationships with other key functions within the organization, and will have direct line management responsibilities.

Job Responsibilities:

• Responsible and accountable for the operational strategy and overall execution of assigned clinical program(s).
• Oversee a team of internal clinical operations professionals (either through direct line management or matrix management) working on the assigned clinical program(s) from start-up through close-out to ensure that both internal and external deliverables are on time and on budget.
• Work cross-functionally to coordinate the relevant and timely exchange of information and materials to support clinical program delivery.
• Ensures program and trial inspection readiness.
• Provide clinical operations technical expertise in the development of documents and processes, where needed.
• Member of assigned program(s) core team providing strategic direction to meet corporate goals and timelines.
• Evaluate CRO/vendor performance and support improvement initiatives/governance.
• Act as an escalation point for study-level team members.
• As a member of the Clinical Operations Leadership Team, this role will contribute significantly to the development and implementation of functional initiatives for role clarity, the way we work, and best practices.
• Participate in the creation, authoring, review, and updating of clinical operations related SOPs, including evaluating the need for new SOPs.
• Manage direct and indirect reports, providing training, coaching, and development for team members.

Skills & Qualifications:

• Bachelor’s Degree is required, advanced degree preferred, with a minimum of 10 years of experience in
• Oncology experience is required.
• Extensive vendor management and project management skills are critical. 
• Excellent written and oral communication skills.
• Strong problem-solving skills and solution-minded approach. Able to quickly identify problems, analyze the issue and rapidly develop solutions.
• Strong working knowledge of GCP/ICH and other applicable regulations/guidelines is required.
• Good organizational/prioritization skills with strong attention to detail and an eye for quality.
• Strong proficiency with MS Office programs such as Outlook, Word, Excel, PowerPoint, and SharePoint is required.
• A collaborative spirit for working successfully with cross-functional teams and partners is essential.
• Ability to travel, including internationally, 10-20%.