Senior Director, Global Safety Lead (m/w/d)

For our GCSP department, we are looking for a
Senior Director, Global Safety Lead (m/f/x)
Fulltime / permanent/ non-tariff
R-225885
The Opportunity
As Senior Director, Global Safety Lead you will provide guidance and expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. You will apply sound medical judgment for analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation and integrate safety risk management activities of the product into their medical, business, and regulatory context.
The Role

• One of your main responsibilities will be to oversee safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials and from the post-marketing environment as well as the safety signal detection and medical signal evaluation process
• You will oversee the analysis of aggregate safety data and the production of key 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.
• Another responsibility will be for you to provide a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities and to support the development of safety materials for First in Human presentations at GSC following SMT review
• You will ensure timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication.
• You will be Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety.
• You will acts as SME during inspections as required and ensure regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function.
• You will set the safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug) / NDA (New Drug Application) filings and initiation of first in human studies
• You will provide pharmacovigilance expertise and medical / scientific advice with regards to the selection of potential product acquisitions through the due diligence process and provide strategic input in license agreements. You will also work to ensure additions to the CSLB portfolio have a promising benefit-risk profile based upon medical and scientific evaluation and that there is transparency internally with respect to potential benefit-risk issues. When needed, you will collaborate with other subfunctions to ensure a smooth transition of PV responsibilities between parties
• As subject matter expert you will represent the company in health authority meetings including FDA Advisory committee meetings and EMA meetings and act as delegate / deputy for TA Head as assigned.
• You will contribute to the onboarding and mentoring of other member of the global team around a clear set of standards and strategic objectives; act as mentor to new Global Safety Leads joining the organization.
  

Your Skills And Experience

• Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency
• Two years minimum working experience as a physician in patient care
• Ten years pharmaceutical / biotechnology industry experience, of which at least five should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management
• Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. e.g. External Audits, Ad Coms, CHMP Oral Explanations, etc.)
• Proven track record of leading safety work to conclusion of key studies in phase 1, 2, and 3
• Experience of responding to safety questions during registration procedures with FDA/EMA/PMDA, taking registration to conclusion
  

What We Offer

• Innovative work-environment at our R&D campus
• CSL-subsidized company bike leasing
• Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old)
• Access to Gym facility on campus
• 2 Wellness days per year (additional paid time off)
• Family services such as psychological support, legal advisory, family care services and more for you and your direct family
  

For more information, please check out our global benefits below.
We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
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 organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!