Director, Clinical Operations

Job Title: Director, Clinical Operations

Job Number: 36137

Location: , 

Job Description

A new opportunity is available for a Director, Clinical Operations to manage at least one oncology trial. In this role, you will oversee the planning, implementation, execution, and management of clinical studies, working closely with internal teams, CRO partners, clinical sites, and third-party vendors. You will thrive in a fast-paced, innovative environment, staying flexible, proactive, and efficient. Additionally, you will mentor junior staff and manage team development. Strong analytical skills, the ability to develop actionable plans, and excellent communication and matrix management abilities are essential. Attention to detail and knowledge of quality obligations are also required.

Responsibilities

• Oversee development of clinical trial timelines, ensuring accurate risk communication, and monitoring metrics.
• Coordinate cross-functional teams to ensure timely exchange of information and materials for clinical trial deliverables.
• Manage trials from start-up to close-out, ensuring timely and budget-compliant deliverables.
• Proactively manage outsourced trial partners and identify risks to ensure goals are met.
• Maintain positive relationships with CROs, addressing issues and escalating to leadership as needed.
• Collaborate with CROs to ensure the clinical study database is accurate and up-to-date.
• Manage scope of work, contract modifications, and budget-related documents for clinical trials.
• Oversee vendor activities to ensure operational excellence.
• Perform additional duties as required.

Required Skills

• BA/BS in nursing, biology, biochemistry, or related field (advanced degree preferred), with 12+ years in clinical research operations.
• At least 2 years of oncology experience required; 5+ years preferred.
• Biotechnology and early-phase experience (including IND submissions) required.
• Strong vendor and project management skills.
• Excellent written and oral communication skills.
• In-depth knowledge of GCP/ICH and relevant regulations.
• Strong organizational and prioritization skills with attention to detail.
• Proficient in MS Office (Outlook, Word, Excel, PowerPoint, SharePoint).
• Collaborative with cross-functional teams and partners.
• Up to 25% travel required.