Director, Pharmacovigilance

Director, Pharmacovigilance

Introduction:

Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area—near Pasadena—and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics, antibodies and cytokines with improved function, with the goal of improving patient outcomes and quality of life. We have an excellent opportunity for a Director, Pharmacovigilance to join our team.

This position will be a hybrid position with 2 days a week onsite in our San Diego, CA. location.

Summary:

Responsible for all aspects of safety related to Pharmacovigilance (PV) processes and the analytical assessment of safety data for assigned product(s).

Job Duties Include:

• Provides day-to-day oversight of PV monitoring activities and processes for assigned product(s)
• Works collaboratively with the PV Medical Director on ICSRs, aggregate data review/signaling, and core risk language for assigned product(s).
• Provides medical review of vendor’s narratives for quality and completeness and ensures timely submission of expedited reports
• Facilitates and leads cross-functional safety data review and signaling meetings; includes setting agenda, coordinating materials, data presentation, and documentation
• Reviews and provides PV input for development of protocols, IBs, ICFs, CSRs and other relevant study documents
• Acts as lead author for aggregate safety reports (e.g., DSURs)
• Leads all efforts related to ad hoc and routine signal evaluation
• Provides PV subject matter expertise on cross-functional platforms and teams throughout the company
• Provides end to end PV support for assigned products including study start up activities, vendor plans, signal detection plans, SAE review, aggregate data review, signaling, aggregate authoring including DSURs, annual core product document updates (IB, ICF), and CSR authoring
• Ensures adherence to GCP/ICH and SOP standards
• Ensures that the above tasks are performed in the most efficient manner possible, commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements
• Ensures that all activities/reviews are compliant with the latest safety standards and regulations
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Performs other duties as required.

Job Qualifications: 

Position requires a bachelor’s degree in nursing, pharmacy, or other healthcare related field and a minimum of 10 years in Pharmacovigilance in the pharmaceutical or biotech industry.  Requires experience in both PV operations and PV analytical work such as signaling, aggregate report authoring and experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical/pharmaceutical information.

Position also requires:

• Knowledge of pharmacovigilance and ability to apply knowledge to the evaluation of safety concerns and minimization of patient risk throughout the life cycle of drug products
• Thorough understanding of the drug development process  in relation to safety surveillance activities in clinical trials
• Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds
• Ability to manage and prioritize multiple projects and demands simultaneously, rapidly adjust to changing priorities, and work effectively under pressure
• Knowledge and understanding of all relevant global PV regulations, FDA, EU and ICH guidelines, initiatives and regulations governing clinical trial safety environments
• Familiarity with Argus safety database
• Knowledge of MedDRA dictionary with relevance to adverse event coding
• Excellent interpersonal skills and professionalism
• Highly innovative and self-motivated
• Excellent time management and organizational skills
• Strong analytical, assessment and problem-solving skills
• Ability to read, analyze and interpret complex clinical data and information
• 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.

Additional Requirements for Laboratory and Research Related Jobs

This role may involve work with experimental subjects and/or specimens including infected samples, plus various Hazardous Materials and infectious agents (Bloodborne Pathogens, or other potentially infections materials (OPIMs). Therefore, the following are also required:

• Ability to follow the established Environmental Health & Safety rules, procedures, and/or BioSafety Guidelines
• Ability to read and understand Safety Data Sheets (SDSs)
• Ability to be available and willing to work some weekends and evenings to conduct and complete experiments
• Knowledge of biosafety techniques and aseptic/gowning practices
• Experience with laboratory safety standards and procedures, including biohazard handling and disposal techniques, and the ability to ensure laboratory compliance with required safety regulations
• Experience working with biological and chemical hazards, infectious agents, bloodborne pathogens and animal allergens
• Experience working in and maintaining a sterile environment
• Experience working with chemical, and biological hazards 
• Thorough knowledge of the operation and maintenance of various lab equipment such as microscopes, centrifuges, spectrophotometers, balances, pH meters, and electrophoresis equipment, freezers, and incubators.

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:  $192,000.00 - $235,000.00

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.