Vice President Clinical Operations

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Vice President, Clinical Operations

COMPANY OVERVIEW:

Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). Azenosertib is being evaluated as a monotherapy and in combination across multiple tumor types in 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.

The Company is also leveraging its extensive experience and capabilities to translate its science to advance research on additional areas of opportunity for azenosertib outside PROC.

POSITION SUMMARY:

Reporting to the Chief Medical Officer, the Vice President Clinical Operations will be responsible for leading and driving clinical trial operations. This role oversees and leads the Clinical Operations team to ensure all operational trial deliverables across programs are completed according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide functional leadership including hiring, training, staff assignments, coaching, mentoring and performance management in a matrix environment
• Lead all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals
• Drive studies in accordance with appropriate quality standards including ICH/GCP, ISO and applicable FDA/global regulations
• Provide strategies to support data dissemination to meet the needs for market registrations by authorities, reimbursement clinical and product marketing and further drug development
• Develop infrastructure build for regulated clinical trial programs; including inspection readiness
• Provide strategic and tactical input into integrated clinical development strategy and timelines
• Develop clinical operations strategy including risk management and contingency planning
• Build strong and highly collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials
• Guide the clinical operations execution activities of all clinical trials in the assigned area and ensure all clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
• Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
• Other projects as deemed appropriate.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• Bachelor’s Degree in life sciences/healthcare is required. Advanced degree is preferred in scientific or health care field or related subject matter and a minimum of 10 years of clinical operations experience in a pharmaceutical or biotech setting
• Successful track record leading global late-stage oncology trials is required, experience with late-stage trials in gynecological malignancies preferred
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Strong leadership, collaborative and interpersonal skills
• Experience interfacing with top-level Executives
• Excellent computer skills (Microsoft Office Suite, Project, Visio, Electronic Data Capture and Trial Master File Systems)
• Experience working independently and in a team environment, being flexible and adapting in a changing environment
• Ability to travel occasionally
• Demonstrated managerial and leadership skills in a dynamic environment running multiple clinical trials
• Demonstrated experience and commitment toward leading an organization focused…