Global Head of Medical Safety, GCSP

The Global Head, Medical Safety leads the long-term strategic medical safety plan for the CSL Behring Global Clinical Safety function as follows:

• He/she directs a team of 20-25 specialized Clinical Safety and Pharmacovigilance professionals, many of whom are physicians, across global sites with high level of cultural diversity in a highly regulated environment.
• He/she leads overall medical safety strategy and risk management of the entire CSL portfolio across all therapeutic areas globally, to position the company to obtain regulatory approval for products in the cutting-edge area e.g. gene therapy. He/she will lead the preparations as well as interactions with Health Authorities on behalf of Safety.
• He/she provides strategic input into clinical development, due diligence and regulatory and issue management activities from a safety perspective and presents the position of Global Clinical Safety in internal governance committees and in discussions with Health Authorities.
• He/she will lead the development of competencies of a team of safety physicians and scientists to position the company in the cutting-edge of safety science.
• He/she will lead the acquisition of advanced safety competencies to CSL, including advanced long-term risk management and advanced signal detection, including the deployment of new technologies.
• He/she is expected to give strategic guidance on global level on various medical, product related and process related matters in a complex environment including many interface departments and functions
• He/she ensure that medical and process standards are in alignment with company policies ensuring patient safety and business needs.

Education

Medical Doctor

Experience

• Minimum four years practical working experience as a physician. Postgraduate medical qualifications preferred.  
• 10+ years in global drug development over the entire product lifecycle.
• Prior leadership experience for a global medical safety area and broad R&D global functional experience.
• Extensive pharmacovigilance experience in a global environment and broad overview of all aspects of a PV system and specific experience in signal detection, risk management and clinical development.
• Track record of accomplishments in management of global and diverse teams and developing people and organizations.
• Experiences of managing successful submissions and interactions with principal regulators e.g. the FDA and the EMA, including FDA’s Advisory Committee and the EMA PRAC’s oral hearing, are preferred.

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.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.