Head of Drug Safety
- Rockville, MD, United States
- Department: Medical Affairs
We are currently developing voclosporin, an investigational therapy, for the treatment of lupus nephritis (LN) and other proteinuric diseases. We are also advancing voclosporin ophthalmic solution (VOS), a topical formulation, for the treatment of dry eye syndrome (DES). And we are actively hunting for other innovative drugs which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.
The Head, Drug Safety is a critically important position within Aurinia Pharmaceuticals, supporting the growth plan of Aurinia by building and leading a strategic and functional vision for the Global Drug Safety Function. The position will require expertise in drug safety strategy, drug safety operations and program development.
Establishing effective collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Medical Affairs and other functional areas to align on a harmonized approach in identifying, evaluating, validating, and communicating safety issues, the Head of Drug safety will be Aurinia’s ambassador for global drug safety.
The responsibilities of this role are three-fold and include programs/pipeline, business and people aspects.
- Manage all pre- and post-marketing safety surveillance activities for Aurinia products (investigational and marketed) throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Drug Safety Practices (GVP), and Aurinia policies and procedures
- Develop, implement and maintain safety surveillance processes and practices that are compliant, robust, and right sized to support Aurinia business model
- Execute all safety surveillance activities ensuring quality, compliance and key performance metrics met for ICSR management, signal and risk management activities, aggregate safety reporting, core safety labeling, responses to regulatory requests for safety information and others
- Lead and/or provide input to global safety strategy for all programs ensuring proactive and continuous review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for all Aurinia programs in collaboration with key stakeholders
- Establish effective collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Medical Affairs and other functional areas to align on harmonized approach in identifying, evaluating, validating, and communicating safety issues
- Coordinate safety data review activities to support program milestones, Data and Safety Monitoring Boards/Data Monitoring Committees, Clinical/Safety Endpoint Adjudication Committees in collaboration with Biometrics, Clinical and other key stakeholders
- Lead multidisciplinary Product Safety Review Committees and other Governance Committees whose responsibilities include signal detection and validation and making recommendations regarding risk management, communication plan and labeling, as appropriate
- Responsible for the development and maintenance of Reference Safety Information (RSI) including Company Core Safety Information (CCSI in the Company Core Data Sheet (CCDS), Investigator Brochure (IB), and/or other product labeling and participate in Labeling forums ensuring accurate safety profile for all Aurinia products
- Lead and/or contribute to risk analyses contributing to benefit-risk profile for Aurinia investigational and commercial products
- Lead the design and implementation of safety risk mitigation strategies (REMS, Risk Management Plan, Post-Approval Safety Surveillance, Enhanced Drug Safety) in collaboration with other stakeholders to ensure the safe and appropriate use of Aurinia approved products in compliance with global regulatory requirements and ensure risk mitigation measures are monitored for effectiveness
- Ensure Drug Safety function collaboration and input for all Aurinia Clinical Development programs including Clinical, Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs; liaise with Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data and Safety Monitoring Boards and Steering Committees and other entities to contribute to overall study execution while ensuring safety monitoring, quality, compliance and operational excellence
- Ensure Drug Safety collaboration and input to support Aurinia Commercial organization global launch activities for all programs
- Direct and oversee medical/scientific assessments of all safety data including the preparation and review of individual case safety reports (ICSRs), data monitoring and safety endpoint adjudication and safety-related section(s) for Drug Safety, clinical, regulatory, and scientific documents including signaling reports, aggregate safety reports (DSURs/PADER/PBRER, 6-monthly SUSAR Line Listings), core safety labeling, protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring accuracy of safety and benefit-risk profiles for all programs
- Provide Drug Safety Leadership in the review, assessment and presentation of new safety findings at Development Technical Review Forum (DTRF) or other Safety Governance forums to communicate product safety/risk profile to key stakeholders.
- Lead the safety aspect of interactions, including input and review of responses to regulatory agency questions, with Regulatory authorities worldwide (FDA, EMA etc.) at type C, B, pre-BLA/MAA/NDS meetings, Advisory Committee meetings, or other scientific advice forums
- Collaborate in the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective
- Maintain knowledge of new Drug Safety/safety regulations and guidance from regulatory authorities
- Maintain knowledge of disease indications for assigned programs
- Establish adequate staffing in drug safety to support the growth of the organization and the vision for drug safety at Aurinia.
- Manage and administer all aspects of people processes related to the employee lifecycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes
- Manage performance and development of staff and direct reports to ensure achievement of organizational and departmental goals and a productive work environment; manage and communicate performance and compensation related information per company guidelines
- Manage and ensure the setting of realistic personal goals and provide regularly scheduled feedback throughout the year.
- Ensure staff receives appropriate knowledge and skill development and growth opportunities through mentoring and training
- Coach and develop staff by providing an environment that encourages ongoing personal and professional growth
- Set operational objectives and business goals for their groups
- Establish and monitor performance measures and objectives for the department
- Establish overall Drug Safety objectives and long-range goals in line to ensure Corporate and Global Drug Safety objectives are met
- Maintain department budget and adherence to business plan and overall goals and objectives of the company
- Contribute to the development and support development of Drug Safety and other Aurinia standard operating procedures
- Lead initiatives for process improvement and overall team effectiveness across programs
- Participate in inspection readiness activities, internal audits, and external inspections
- Support overall company strategy and corporate business development activities by providing Drug Safety medical/scientific expertise in due diligence, partnership committees, and other task groups
- Bachelor’s level degree with advanced degree preferably in scientific field; Healthcare professional degree (MD, MPH, PharmD, PhD, RPH)
- A minimum of 12 years in a senior/advanced Drug Safety Science role within the pharmaceutical/biotechnology industry, with at least 5 years in supervisory capacity; other relevant experience may be considered
- Proven ability in creating a strategic and functional vision for drug safety through to implementation of a competent drug safety team in a similar stage pharmaceutical/biotechnology company
- Strong people management skills, willingness to help others develop and succeed
- Outstanding leadership qualities with technical and emotional intelligence
- Excellent communication and influencing skills within the function (up and down) as well as cross-functional; success influencing executives and senior level scientific management including boards as well as external representation of company (e.g., investors)
- Requires high level of initiative and independence
- Ability to navigate a fast-paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must
- Able to interface well with all levels of personnel, including peers and other Development and Commercial department heads such as: Biometrics, Clinical Development, Clinical Operations, Commercial, Medical Affairs, Program Management, Regulatory Affairs, Quality
- Capacity to produce high quality results across multiple programs and non-program initiatives and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment
- Demonstrated knowledge of pharmaceutical research and development, global safety and Drug Safety regulatory environment with working knowledge of international regulations including but not limited to FDA, EMA, ICH guidelines and regulations pertaining to clinical development and post-marketing safety and their interpretation
- The ability to travel nationally/international as required
All candidate information will be kept confidential according to EEO guidelines.