Zentalis Pharmaceuticals

Senior Director, Clinical Operations

Zentalis Pharmaceuticals

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $255,000 - $290,000 per year

Job Level

Senior

About the role

  • 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

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical trial managementclinical standard operating proceduresclinical trial master filesclinical operationsbudget managementschedule managementperformance requirementsdata accuracy verificationclinical trial program implementationglobal clinical trial experience
Soft skills
leadershipmanagementflexibilityadaptabilitymulti-taskingtime managementattention to detaileffective communicationorganizational skillsteam-oriented