Associate Director, Clinical Trial Management (Autoimmune)

Introduction:Xencor•San Diego, CA

6d•Hybrid

About The Position

Xencor is a public, clinical-stage biopharmaceutical company focused on developing high-potential XmAb® bispecific T-cell engagers and other engineered drug candidates. The company leverages its differentiated technology platforms to advance its pipeline toward clinical proof-of-concept decisions, aiming to create high-impact therapeutics for patients with cancer and other serious diseases. Several XmAb drug candidates are in clinical development, and some XmAb medicines are marketed by partners. This role is for an Associate Director, Clinical Trial Management with experience in autoimmune diseases, offering a hybrid work arrangement with two days per week onsite at either the San Diego or Pasadena, CA offices.

Requirements

Bachelor’s degree in a field of science (such as Biology or Immunology)
At least 10 years of related experience
Including 6 years in clinical trial management/clinical operations departments
At least 2 years of people management experience is also preferred
Experience working at the Sponsor level within a biotech company is required
Experience with autoimmune indications, such as Irritable Bowel Disease, and Rare Autoimmune Diseases is required
Strong knowledge of global regulations
Expert knowledge of ICH-GCP
Excellent time management and organizational skills
Excellent attention to detail and accuracy in work
Ability to complete critical tasks on time with a high level of quality
Ability to establish and maintain effective working relationships with coworkers, managers and vendors
Computer skills including proficiency in use of Microsoft Outlook, Word, Excel, PowerPoint and Microsoft Project
Ability to think critically and creatively and to work independently to determine appropriate actions to resolve complex problems
Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and corporate goal accomplishment.

Responsibilities

Accountable for the management of the end-to-end execution of Xencor’s investigational global clinical trials (Phase 1 to Phase 3 clinical studies).
Leads a cross-functional study team to ensure all elements of the study are addressed proactively by the relevant parties, follows up on action items, proactively identifies and resolves operational issues and is accountable for the overall study performance, budget and timeline in accordance with the company corporate goals.
Oversee third-party vendor activities (e.g. CRO and other external vendors) tracking all outsourced aspects throughout the life of the clinical trial.
Contributes as a subject-matter expert to the review of protocols for operational feasibility and consistency.
Initiates Requests for Proposal analyses of CROs and external vendors, as applicable.
Attends/leads bid defense meetings and ensure adequate feasibility assessment for country and site selection, including projected enrollment rate that track to the clinical program timeline.
Tracks country approval, site activation, and patient enrollment/treatment status and proactively addresses obstacles with a solution-oriented approach.
Tracks protocol deviations, data completion and metrics and ensure compliance with ICH GCP and regulatory standards.
Conducts clinical data review and addresses observed trends, including training of CRAs, vendors and investigational sites, as applicable.
Assists in the development and review of key study documents (e.g., Protocol, Informed Consent Form, Trial Management Plan and other study plans, Laboratory and Pharmacy Manuals, Case Report Forms, etc.) keeping critical path study timeline in mind.
Participates in Clinical Operations initiatives and specialty projects as assigned, including identifying areas of best practice, process improvements and review of SOPs.
Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching.
Performs other duties as required.
Adheres to all department and company-wide policies regarding conduct, performance and procedures