Xencor Inc., is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including six programs currently in clinical testing, with two more expected to start clinical testing by 1H2019. We have an excellent opportunity for a Director/Senior Director, Drug Safety and Pharmacovigilance to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and that have the potential to be more potent, safer, and longer lasting – with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with twelve in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, CSL, Alexion, and Boehringer Ingelheim.
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 to 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.
We seek a Director/Senior Director, Drug Safety and Pharmacovigilance, reporting to the Chief Medical Officer, to oversee the implementation and coordination of safety surveillance processes and procedures for the Drug Safety and Pharmacovigilance functional area, including development and review of safety reports, assessment of safety signals, and contribution to clinical and regulatory documents. This includes development of proactive strategies to prevent risk and to promote the safety of patients enrolled in Xencor-sponsored studies. The Director/Senior Director, Drug Safety and Pharmacovigilance must demonstrate knowledge of regulatory requirements (FDA, ICH, EMA, etc.) pertaining to drug safety/pharmacovigilance/benefit risk management, and be able to lead and provide medical safety input of clinical and regulatory documents/responses, deal with safety-related issues using critical medical and regulatory analytical strategies, develop optimal solutions, and communicate with internal and external stakeholders. These activities will be done using best practices associated with drug safety and pharmacovigilance and will be done in close collaboration with Clinical Development, Clinical Operations, Biometrics and Regulatory Affairs.
• Advise on pharmacovigilance aspects of clinical studies; write or advise on safety sections of study-related documents, including protocols, investigator brochures, reference safety information, informed consent forms, CSRs, etc.
• Perform medical review and assessment of safety reports
• Ensure consistency in the initial evaluation and assessment of the safety report and source documentation
• Write or review and approve content of final MedWatch/CIOMS reports, including medical coding and case narratives
• Create analysis of similar events and provide company assessment for all serious reports, as required
• Perform periodic review of safety data listings
• Write safety sections of regulatory documents (e.g., DSURs), authoring analysis and content, as required
• Collaborate closely with medical monitors to effectively identify, assess, and evaluate safety concerns, as they arise. Advise on appropriate measures taken to address potential safety issues that may impact the benefit/risk balance of the product or jeopardize patient safety.
• Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues
• Monitor the benefit/risk profile of Xencor clinical candidates
• Engage in risk minimization and management activities; author and maintain product-specific risk management plans
• Respond to safety-related queries from regulatory authorities, IRBs/ECs
• Maintain knowledge of relevant therapeutic area diseases for assigned products
• Assist in the development and review of drug safety/pharmacovigilance SOPs and work instructions
• Take responsibility for inspection readiness for medical assessment activities and support regulatory inspections when needed
• Maintain an understanding of SOPs, work instructions, global regulations (FDA and EU directives), GCPs, and ICH guidelines
• Interact effectively with multiple functional areas including Clinical Development, Clinical Operations, Data Management, and Regulatory Affairs
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note that 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.
• Extensive current knowledge of medical aspects of pre- and post-marketing drug safety
• Experience with ICSR case review and aggregate safety analysis and reports
• Ability to deal with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions
• Ability to perform effective review of complex medical documents
• Proficiency in the processing, assessment, discussion, and presentation of safety data
• Critical thinking and analytical skills and ability to make high-level decisions with an understanding of the result or impact
• Ability to work collaboratively and effectively with cross-functional teams
• Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition
• Demonstrated computer literacy, with experience working with safety databases
• Self-motivation with the ability to work independently with attention to detail and quality
• Strong organizational, documentation, oral/ written (English), and interpersonal skills
• Medical degree required or internationally recognized equivalent
• Minimum of 8 years' experience in pharmacovigilance, clinical research, or clinical development, including a minimum of 5 years in a global pharmacovigilance organization with exposure in pre and post-marketing oncology studies
• Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data
• Previous experience in the development and growth of a drug safety and pharmacovigilance function is a strong plus.
• Experience with safety databases. Knowledge of principles of epidemiology and statistics will be a plus.
• Experience in a small biotechnology company is a plus.
For qualified candidates in their respective fields, we offer a competitive salary and benefits package. For further information about Xencor, please visit our website at www.xencor.com.