Director Clinical Operations

Director Clinical Operations

Company: Zentalis Pharmaceuticals

DIRECTOR, CLINICAL OPERATIONS

Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers. The Company’s lead product candidate, azenosertib (ZN-c3), is a potentially first-in-class and best-in-class WEE1 inhibitor for advanced solid tumors. Azenosertib is being evaluated as a monotherapy and in combination across multiple clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types and in combination with several chemotherapy backbones. As part of its azenosertib clinical development program, the Company is exploring enrichment strategies targeting tumors of high genomic instability, such as Cyclin E1 positive tumors and tumors with oncogenic driver mutations. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders.

POSITION SUMMARY:

The Director, Clinical Operations is responsible for leading assigned clinical program(s) and for managing studies in alignment with Zentalis’ development goals. This individual manages program execution, including quality, timelines, budget, vendor oversight, and resourcing. The Director, Clinical Operations also develops and implements best practices and may lead strategic initiatives. The role reports to the Vice President, Clinical Operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Hands-on management and oversight of multiple clinical trial study deliverables through clinical study teams and other external resources, such as contract research organizations and laboratories
• Manage operational plans and timelines to achieve on-time enrollment and study completion
• Oversee trial-level budgeting and resource planning and management
• Management of CRO, laboratory, and other vendors, site operations/monitoring, and data delivery milestones in line with corporate goals
• Identify barriers to timely and successful study execution and propose solutions, with regular reporting of program performance metrics
• Collaborate with senior management to develop project timelines, study budgets, and report periodically on project status to all stakeholders
• Ensure compliance with all regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), GCP, FDA, ICH, and applicable international regulations concerning clinical activities
• Review informed consent forms, ensuring that they agree with the protocols and required elements
• Critical oversight of CROs and external vendors in conjunction with study managers to ensure compliance and proper conduct of the protocol and regulatory requirements using appropriate Quality Assurance procedures
• Manage the activities of both internal and external resources
• Identify additional resource requirements based on business needs to meet goals and milestones
• Maintenance of clinical trial master files and other clinical documents to ensure inspection readiness at all times
• Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
• May lead continuous improvement projects and other strategic initiatives

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• BA/BS or MS with at least 8-10 years' progressive leadership and management experience in Clinical Operations (Oncology related) in pharmaceutical or biotechnology industry
• Proven track record in overseeing multiple studies and in successful implementation and completion of clinical trial programs
• Global Clinical Trial Experience and the ability to support more than one clinical trial
• Experience working independently and in a team environment, being flexible and adapting in a changing environment
• Ability to travel up to 25%
• Ability to multi-task/ prioritize and time management of daily activities
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project)
• High attention to detail
• Demonstrates high level of accuracy and effective oral and written communication skills
• Flexibility within a rapidly changing environment
• Excellent ability to work in a goal and team-oriented setting
• Well-developed organizational skills