Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. In the six years since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.
SUMMARY
Responsible for working on the company's clinical operations plans. Responsible maintaining quality standards across the clinical organization.
RESPONSIBILITIES
- Work on clinical trial study deliverables through clinical study teams and other external resources, such as contract research organizations, laboratories
- Manager the implementation of clinical standard operating procedures (SOPs) that meet ICH and FDA requirements
- Provide guidance to 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
- 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
- Other projects and tasks as assigned
QUALIFICATIONS
- A bachelor’s degree or equivalent with 8 years' progressive leadership and management experience in Clinical Operations (Oncology related) 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 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
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