The Opportunity
Located within CSLB’s GCSP department, the Director, Global Safety Lead Translational Medicine provides expertise on all aspects of safety in the evaluation of pre- and early clinical assets. You will apply sound scientific and medical judgment in the analysis and interpretation of safety data from all relevant sources, including: literature, research, data science, academia for signal detection and initiation of safety risk management activities. This includes development of the safety specification, PV planning and risk minimization/mitigation.
You will integrate the safety risk management planning for the assets in focus into the clinical, business and regulatory contexts of the projects.
You will be the safety representative in the research and early clinical development teams and is responsible for setting the safety strategy for the latest projects.
Familiarity with CSL Processes is needed for success in the role.
You will also ensure that the medical and process standards delivered follow safety goals expected of manufacturers by partners including regulators, regulatory agencies, payors, physicians, and patients:
Complying with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities.
Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure.
Promoting the safe and effective use of medicinal products in particular through providing information about the safety of medicinal products to patients, healthcare professionals and the public.
You will work with high-level partners and contribute to and approves regulatory reports / submissions / queries. You will provide strategic input into pre-clinical and clinical development, regulatory and issue management activities and represent the position of GCSP in internal governance committees.
The Role
Safety Surveillance and Risk Management: You will lead the safety management teams ensuring a consistent approach to the review of emerging safety data. Oversee the safety signal detection and medical signal evaluation process. Analyze aggregate safety data and the production of important company documents, such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion. Provide a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring
Translational Safety Development of the CSLB portfolio:: You will ensure efficient evaluation of early clinical assets. Support the set-up of the preclinical package for the candidate drugs. Analyze existing preclinical data packages and identify risks and potential benefits, and the need for supplementary data to investigate already identified risks, or gaps data. Develop a risk mitigation strategies for the FIH/Phase 1 studies to protect study subjects and ensure reliable management of safety signals.
Quality Management: Ensure production of aggregate reports and answers to queries from Health Authorities according to quality standards
Regulatory Agency Requests: Responsible for responses to Regulatory Agency requests relating to patient safety.
Inspections: Ensure regulatory agency inspection findings and internal audit findings are addressed and resultant Corrective Action Plans (CAPA plans) are implemented.
Clinical Safety: On an ad hoc basis: oversee all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products. Set the strategy, reviews and approve filing documents including ISS, SCS, and risk management plans. Provides major contributions to current and potential safety issues, setting up any additional systems to mitigate risk in CSLB’s studies.
Clinical Safety Representation: Lead the Safety Management Team (SMT) and represents GCSP in relevant teams.
REPORTING RELATIONSHIP
You will report to the Therapeutic Head of Immunology
Your experience
Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
Experience
2+ Years working experience as a physician in patient care.
3+ years pharmaceutical / biotechnology industry experience, preferably in a safety role.
Competencies
Knowledge of scientific data relevant to own products and across therapeutic areas, including the competitive environment and the disease state
Understanding the important components of data capture, data management and statistical methods for preparing and analyzing safety data in clinical trials.
Understanding of important manufacturing aspects relevant to the safety of own portfolio
Perform qualitative and structured benefit-risk assessments for own products and across the therapeutic area portfolio
Selecting the appropriate important benefits and risks, building a value tree, and promoting other important elements such as uncertainty, unmet medical need and alternative treatment options
Signal and Risk Management
Identifying literature sources and specifying search terms/filters for the identification and evaluation of signals.
Incorporating RWE into signal identification and signal assessment
Prioritizing and escalating signals to the appropriate level in the organization
Evaluating signals for causality; identifying, classifying, and determining the impact of risk and confounding factors; conducting follow-up investigations
Managing signals across the product lifecycle using technology deployed at GCSP to manage safety signals
Predicting potential risks and drafting risk mitigation strategies based on preclinical data
Developing and executing risk mitigation and minimization strategies across the product lifecycle Selecting and using appropriate tools to evaluate the effectiveness of risk minimization and mitigation measures
-PV & R&D Knowledge.
Structure, important partners, and interdependencies of the PV system
CSL’s safety and benefit-risk governance framework
Business environment of a pharmaceutical company and how safety decisions can Affect other departments and patients.
PV concepts (e.g., CIOMS, listedness/expectedness, causality assessment, common AE grading and coding conventions, ICSR mgmt.)
PV documents and safety sections of documents (e.g. PBRER, RMP)
Safety sections/required safety contributions to regulatory submission documents (e.g., as part of MAA, renewals, CTD, IB, etc.).
Labelling principles and important regional differences in displaying safety info.
Product development process, the relevant scientific principles, and roles of contributing functions (e.g., clin dev, toxicology, epi, biostats and regulatory affairs)
Relevant regulations and regulatory milestones including timing of important opportunities to have an open dialogue with Health Authorities
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
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