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Sr Director Clinical Operations
6 hours ago
Sr Director 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.
JOB SUMMARY:
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.
ESSENTIAL DUTIES AND 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
EDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
- 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
