Sr Director Clinical Operations

Zentalis•Island or Peninsula of San Diego, CA

About The Position

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. The Sr Director, Clinical Operations is responsible for developing and executing effective clinical operations plans and for overseeing delivery of multiple clinical trials. Maintains quality across the clinical organization, including by developing and managing Standard Operating Procedures and ensuring readiness for health authority inspections. Manages and actively develops a team of clinical operations professionals.

Requirements

Advanced degree with 10+ years progressive leadership and management experience in clinical operations in pharmaceutical or biotechnology industry
Proven track record 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 40%
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

Responsibilities

Manage clinical trial study deliverables through clinical study teams and other external resources, such as contract research organizations, laboratories
Maintain business information and timelines: ensure budgets, schedules, and performance requirements for clinical programs are met
Create, implement, and manage clinical standard operating procedures (SOPs) that meet ICH and FDA requirements
Ensure SOPs are followed across all programs, including with CROs, outside labs, and other third-party vendors
Manage the activities of both internal and external resources
Provide oversight for the establishment and maintenance of clinical trial master files and other clinical documents
Lead clinical operations preparation for health authority inspections
Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
Actively develop team capabilities and help drive staff’s individual professional growth
Ensure effective clinical operations vendor oversight
Other projects as deemed appropriate