Associate Director, Clinical Trial Management (Autoimmune)
Xencor
14 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Summary:
- Responsible for day-to-day management of global clinical trials across early and 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:
- Manage end-to-end execution of global investigational trials (Phase 1–3).
- Lead cross-functional study teams; follow up on action items; proactively identify and resolve operational issues; accountable for study performance, budget, and timeline.
- Oversee third-party vendors (e.g., CROs and external vendors) across the trial lifecycle.
- Review protocols for operational feasibility and consistency.
- Conduct RFP analyses of CROs/external vendors; attend/lead bid defense meetings; ensure feasibility for country/site selection and projected enrollment.
- Track approvals, site activation, and patient enrollment/treatment status; address obstacles; track protocol deviations and data completion; ensure ICH GCP/regulatory compliance.
- Perform clinical data review; address trends; train CRAs, vendors, and investigational sites as applicable.
- Assist in development/review of key study documents (e.g., Protocol, ICF, Trial Management Plan, Manuals, CRFs), maintaining critical-path timelines.
- Participate in clinical operations initiatives and process/SOP improvement projects.
- Provide oversight/direction to direct/indirect reports (recruiting, training, coaching, performance management) as applicable.
Education/Experience/Skills (Requirements):
- Bachelor’s degree in a science field; 10+ years related experience including 6 years in clinical trial management/clinical operations.
- Sponsor-level biotech experience required.
- Autoimmune indication experience (e.g., IBD and rare autoimmune diseases) required.
Position also requires:
- Strong global regulations knowledge; expert ICH-GCP.
- Time management, organizational skills, attention to detail, and ability to deliver high-quality work on time.
- Relationship-building with coworkers/managers/vendors.
- Proficiency with Microsoft Outlook, Word, Excel, PowerPoint, and Microsoft Project.
- Ability to think critically/independently to resolve complex problems.
- Ability to coach and supervise others.
Travel: Occasional travel; full-time commitment.
Application: See https://xencor.com/careers/.
- Responsible for day-to-day management of global clinical trials across early and 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:
- Manage end-to-end execution of global investigational trials (Phase 1–3).
- Lead cross-functional study teams; follow up on action items; proactively identify and resolve operational issues; accountable for study performance, budget, and timeline.
- Oversee third-party vendors (e.g., CROs and external vendors) across the trial lifecycle.
- Review protocols for operational feasibility and consistency.
- Conduct RFP analyses of CROs/external vendors; attend/lead bid defense meetings; ensure feasibility for country/site selection and projected enrollment.
- Track approvals, site activation, and patient enrollment/treatment status; address obstacles; track protocol deviations and data completion; ensure ICH GCP/regulatory compliance.
- Perform clinical data review; address trends; train CRAs, vendors, and investigational sites as applicable.
- Assist in development/review of key study documents (e.g., Protocol, ICF, Trial Management Plan, Manuals, CRFs), maintaining critical-path timelines.
- Participate in clinical operations initiatives and process/SOP improvement projects.
- Provide oversight/direction to direct/indirect reports (recruiting, training, coaching, performance management) as applicable.
Education/Experience/Skills (Requirements):
- Bachelor’s degree in a science field; 10+ years related experience including 6 years in clinical trial management/clinical operations.
- Sponsor-level biotech experience required.
- Autoimmune indication experience (e.g., IBD and rare autoimmune diseases) required.
Position also requires:
- Strong global regulations knowledge; expert ICH-GCP.
- Time management, organizational skills, attention to detail, and ability to deliver high-quality work on time.
- Relationship-building with coworkers/managers/vendors.
- Proficiency with Microsoft Outlook, Word, Excel, PowerPoint, and Microsoft Project.
- Ability to think critically/independently to resolve complex problems.
- Ability to coach and supervise others.
Travel: Occasional travel; full-time commitment.
Application: See https://xencor.com/careers/.