Xencor is an innovative, clinical-stage biotechnology 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 other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Pharmacovigilance Scientist/Associate Medical Director to join our team.
Our protein engineering capabilities and the modular nature of our technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are developing a broad portfolio enabled by the rapid expansion of our bispecific technologies, and nine XmAb bispecific antibodies and cytokines are in clinical testing. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. Including our partners, over a dozen XmAb drug candidates are advancing through clinical development, and the first antibody that incorporates an XmAb technology has been approved for commercial marketing worldwide.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
Job Duties include:
• Perform medical review of clinical individual case safety reports (ICSRs), including confirmation of triage and assessment, review of narratives and company comments.
• Participate in safety signaling activities for assigned products.
• Review of clinical trial documents (protocols, IBs, safety and medical monitoring plans, SOPs, etc.)
• Participate in the preparation and maintenance of Reference Safety Information (RSI), periodic reports and associated activities.
• Analyze and interpret clinical safety data (i.e. Lab values, adverse events, potential signals, etc.).
• Work collaboratively with the Safety team and a CRO in reviewing SAEs and/or Pregnancy reports across all studies.
• Provide support in signaling activities and Literature reviews.
• Provide medical evaluation of aggregate safety data, develop and write medical sections of periodic and ad hoc safety reports.
• Ensure adherence to GCP/ICH and SOP standards.
• Provide a medical perspective into departmental standards and support improvement process and initiatives.
• Participate in Safety Management Team (SMT) meetings, if needed.
• Ensure 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.
• Ensuring that all activities/reviews are compliant with the latest safety standards and regulations.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• A Medical Degree (MD, DO or equivalent ex-US medical degree) is required.
• Solid knowledge of General Medicine, clinical expertise, ability to exercise conservative clinical judgment and identify relevant safety findings are required.
• Minimum of 3 years' experience in drug safety/pharmacovigilance or medical monitor experience.
• Postgraduate qualification or experience in oncology, or related specialty is desirable
• Experienced in the evaluation and interpretation of clinical study and safety data.
• Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug products.
• Experience in safety reviews of AEs/SAEs, IBs, protocols, CSRs, informed consents, and other safety-related documents.
• Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure.
• Demonstrated knowledge of relevant 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.
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at www.xencor.com EOE
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.
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