Director, Clinical Trial Management (Oncology)
Xencor
16 days ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Director, Clinical Trial Management (Hybrid: 2 days/week onsite in San Diego or Pasadena, CA)
Summary:
Responsible for day-to-day management of global clinical trials across early to late-stage programs, coordinating cross-functional teams and overseeing CROs/external vendors to deliver studies on time, within budget, and in compliance with quality and regulatory standards.
Job Duties:
- Accountable for end-to-end execution of global investigational Phase 1–3 trials.
- Lead late-stage clinical development, including BLA/NDA preparation and submission.
- Lead cross-functional study teams; track actions; proactively identify/resolve operational issues; ensure study performance, budget, and timeline.
- Oversee third-party vendor activities throughout the trial lifecycle.
- Review protocols for operational feasibility and consistency.
- Conduct RFP analyses; attend/lead bid defense meetings for country/site feasibility and enrollment projections.
- Track approvals, site activation, and patient enrollment/treatment status; address obstacles.
- Track protocol deviations and data completion; ensure ICH GCP and regulatory compliance.
- Conduct clinical data review and address trends; train CRAs/vendors/sites as applicable.
- Assist with development/review of key study documents (protocol, informed consent, trial management plan, manuals, CRFs).
- Participate in Clinical Operations initiatives/SOP and process improvement; assist with resourcing and organization structure.
- Provide oversight/direction to direct/indirect reports (recruiting, training, performance management, coaching).
Qualifications/Experience:
- Bachelor’s degree in a science field.
- 12+ years related experience (15+ preferred); 8+ years in clinical trial management/clinical operations.
- 5+ years people management experience.
- Sponsor-level biotech experience.
- Oncology solid tumors experience.
Required/Preferred Skills:
- Expert knowledge of global regulations and ICH-GCP.
- Strong time management, organization, attention to detail, and ability to deliver critical tasks on time with high quality.
- Ability to build effective relationships with coworkers, managers, and vendors.
- Proficiency with Microsoft Outlook, Word, Excel, PowerPoint, and Microsoft Project.
- Ability to think critically/creatively and work independently on complex problems.
- Demonstrate leadership competency model capabilities; coach/supervise per policies.
Benefits/Compensation:
- Expected base salary range: $211,500–$250,900.
- Eligible for annual bonus and equity grant; 401k match, healthcare coverage, and ESPP.
Application Instructions:
- For more information, see https://xencor.com/careers/.
Summary:
Responsible for day-to-day management of global clinical trials across early to late-stage programs, coordinating cross-functional teams and overseeing CROs/external vendors to deliver studies on time, within budget, and in compliance with quality and regulatory standards.
Job Duties:
- Accountable for end-to-end execution of global investigational Phase 1–3 trials.
- Lead late-stage clinical development, including BLA/NDA preparation and submission.
- Lead cross-functional study teams; track actions; proactively identify/resolve operational issues; ensure study performance, budget, and timeline.
- Oversee third-party vendor activities throughout the trial lifecycle.
- Review protocols for operational feasibility and consistency.
- Conduct RFP analyses; attend/lead bid defense meetings for country/site feasibility and enrollment projections.
- Track approvals, site activation, and patient enrollment/treatment status; address obstacles.
- Track protocol deviations and data completion; ensure ICH GCP and regulatory compliance.
- Conduct clinical data review and address trends; train CRAs/vendors/sites as applicable.
- Assist with development/review of key study documents (protocol, informed consent, trial management plan, manuals, CRFs).
- Participate in Clinical Operations initiatives/SOP and process improvement; assist with resourcing and organization structure.
- Provide oversight/direction to direct/indirect reports (recruiting, training, performance management, coaching).
Qualifications/Experience:
- Bachelor’s degree in a science field.
- 12+ years related experience (15+ preferred); 8+ years in clinical trial management/clinical operations.
- 5+ years people management experience.
- Sponsor-level biotech experience.
- Oncology solid tumors experience.
Required/Preferred Skills:
- Expert knowledge of global regulations and ICH-GCP.
- Strong time management, organization, attention to detail, and ability to deliver critical tasks on time with high quality.
- Ability to build effective relationships with coworkers, managers, and vendors.
- Proficiency with Microsoft Outlook, Word, Excel, PowerPoint, and Microsoft Project.
- Ability to think critically/creatively and work independently on complex problems.
- Demonstrate leadership competency model capabilities; coach/supervise per policies.
Benefits/Compensation:
- Expected base salary range: $211,500–$250,900.
- Eligible for annual bonus and equity grant; 401k match, healthcare coverage, and ESPP.
Application Instructions:
- For more information, see https://xencor.com/careers/.