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, Drug Safety & Pharmacovigilance, to join our team.
This position will be based in San Diego, CA. and have 2 days a week hybrid on-site. Potentially for fully remote if not local to San Diego.
Summary:
Responsible for all aspects of safety related to Drug Safety & Pharmacovigilance (PV) processes and the analytical assessment of safety data for assigned product(s).
Primary Responsibilities:
- Provides day-to-day oversight of safety monitoring activities and processes for assigned product(s)
- Works collaboratively with the Medical Monitor/Clinical Scientist on ICSRs, aggregate data review/signaling, and core risk language for assigned product(s).
- Provides clinical review of vendor’s narratives for quality and completeness and ensures timely submission of expedited reports. Contributes to the creation of analysis of similar events.
- Facilitates and leads cross-functional safety data review and signaling meetings; includes setting agenda, coordinating materials, data presentation, and documentation.
- Reviews and provides safety functional 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 efforts related to ad hoc and routine signal evaluation
- Provides Drug Safety/PV subject matter expertise on cross-functional platforms and teams throughout the company
- Provides end to end Drug Safety/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 as well as informed consent forms, integrated summaries of safety, marketing applications and other regulatory submission documents on assigned products.
- Collaborates with partners on safety monitoring, signal detection and risk management activities.
- Participates in establishing and maintaining Safety Data Exchange Agreements/Pharmacovigilance Agreements.
- Ensures adherence to GCP/ICH and SOP standards
- Participates in inspection readiness activities and preparation.
- 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
- 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 assigned.
Education/Experience/Skills:
Required -
- Advanced nursing degree or PharmD
- At least 8 years drug safety experience
- At least 5 years managing medical case review and signal detection
- At least 4 years of clinical experience
Preferred -
- MD
- Experience in a critical care setting
- Experience in oncology and/or autoimmune drug development
Position also requires:
- Solid experience with work such as signaling, aggregate report authoring and experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical information.
- Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection
- Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange and/or pharmacovigilance agreements
- Excellent written and oral communication skills
- Excellent interpersonal skills and ability to work effectively as part of a team(s)
- 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 and training on MedDRA dictionary with relevance to adverse event coding
- Excellent interpersonal skills and professionalism
- 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.
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: $206,000 - $255,000
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/.
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.
