Director, Clinical Trial Management (Oncology)

Xencor•San Diego, CA

7d•$211,500 - $250,900•Hybrid

About The Position

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Director, Clinical Trial Management with experience in Oncology to join our team. This is a hybrid position with 2 days a week onsite from either our San Diego or Pasadena, CA offices. The Director, Clinical Trial Management is responsible for the day-to-day management of global clinical trials across our early to late-stage Xencor programs, coordinating internal cross-functional teams and overseeing CROs and external vendors to ensure studies are delivered on time, within budget, and in compliance with quality and regulatory standards. This role requires hands on involvement in clinical trial execution, proactive identification and resolution of operational issues, and accountability for study performance metrics and deliverables quality. The position also requires strong leadership and communication, risk management, and process improvement skills.

Requirements

Bachelor’s degree in a field of science (such as Biology or Immunology)
At least 12 years of related experience (15 or more preferred)
At least 8 years in clinical trial management/clinical operations departments
At least 5 years of people management experience
Experience working at the Sponsor level within a biotech company
Experience in Oncology solid tumors
Expert knowledge of global regulations and 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.
Work for this position requires full-time commitment.

Nice To Haves

15 or more years of related experience

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).
Ability to manage late-stage global clinical development trials, BLA/NDA preparation and submission resulting in approval of a marketed product.
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 Forms, 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.
Assists with the development of department organization structure and resourcing identification and allocation.
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