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Director, Clinical Trial Management

Xencor San Diego Office, 12770 El Camino Real, San Diego, California, United States of America Req #81
Monday, October 14, 2024

Director, Clinical Trial Management

Introduction:

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 to join our team.

 

This position can be hybrid 2 days a week onsite in our San Diego, CA. office or Fully Remote, preferably West Coast working hours

 

Summary:

Responsible for directing tactical implementation of the clinical development plan by managing the timeline, resources, budget, and staff of clinical activities. 

 

Job Duties:

  • Guides study team in vendor selection and provides management oversight throughout the life of all assigned clinical projects, proposes vendors for approval.
  • Ensures operational feasibility of clinical development plans and scenarios, including time, budget, and resource requirements
  • Analyzes protocol to produce investigational product (IP) forecasts, identify IP import and regulatory issues, IP distribution and storage requirements, and IP labeling requirements
  • Works with senior management to develop and to achieve corporate goals and work with clinical operations staff to achieve the established corporate goals within the expected time frames
  • Manages and leads the day-to-day clinical trial activities related to the development and execution of cross-functional and third-party vendor activities and deliverables, including but not limited to, development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines, edit check specifications, database build, query resolution and database cleaning), relevant study plans (e.g. monitoring, study operations, quality, communications, etc.), protocol review for operational feasibility and consistency, tracking site selection and activation and patient recruitment and tracking to project timelines
  • Serves as Clinical Operations leader and main point of contact with counterparts of outside vendors, CRO and/or trial sites
  • Conducts daily reviews to identify potential issues or problems and communicates/escalates to Clinical Lead/Project Team
  • Develops, maintains and promotes effective and collaborative working relationships with and among internal team members and external vendors and 3rd party personnel
  • Participates in Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs and department level training and cross project initiatives
  • Prepares and maintains Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents
  • Informs the Clinical Lead/Project Team of outstanding documents
  • Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests
  • Leads review of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures
  • Performs in-house review of site monitoring reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues
  • Develops and maintains tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product (IMP) and clinical supplies to Sites, Vendors and CROs
  • Supports financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders
  • Tracks patient and recruitment status using applicable spreadsheets and web portal tools
  • Assists in the critical development and review of key study documents (e.g., Protocol, ICF, study plans, eCRF etc.)
  • Assists with the development of department organizational structure.
  • Adheres to all department and company-wide policies regarding conduct, performance and procedures
  • 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, and providing career development planning and opportunities
  • Performs other duties as required.

 

Education/Experience/Skills:

Position requires a Bachelor’s degree in a field of science such as biology or chemistry, a degree in nursing or pharmacy is preferred, and at least 12 years of related experience, including 8 years in clinical trial management.  At least 5 years of people management experience and experience working in a small company in the biotech or pharma industry also required. Experience with autoimmune indications, including Irritable Bowel Disease, Ulcerative Colitis, etc. preferred

 

Position also requires:

  • Expert knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Excellent time management and organizational skills
  • Excellent attention to detail and accuracy in work, completing critical tasks on time with quality
  • Ability to establish and maintain effective working relationships with coworkers, managers and vendors
  • Computer skills including proficiency in use of Microsoft Outlook, Word, PowerPoint and Microsoft Project
  • Ability to think critically and creatively and 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 goal accomplishment.

 

Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

 

Expected Base Salary Range:  $182,000 - $210,000

 

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits.  In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

 

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.  Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen.  New employees will be required to provide proof of their COVID-19 vaccination status as of their start date unless an exemption or accommodation is approved.

 

Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

 

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

 

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.

 

 

Other details

  • Job Family Director Jobs
  • Pay Type Salary
  • Employment Indicator Hybrid
  • Min Hiring Rate $182,000.00
  • Max Hiring Rate $210,000.00
Location on Google Maps
  • Xencor San Diego Office, 12770 El Camino Real, San Diego, California, United States of America