BioMarin Pharmaceutical seeks a highly experienced dynamic leader and manager to head up the Safety Science (SS) group within BioMarin’s Pharmacovigilance department (BPV), which consists of safety physicians, pharmacists and other PV specialists.
The head of SS oversees safety surveillance practices for BioMarin’s portfolio of marketed and development products in collaboration with other functions within Worldwide Research and Development (WWRD).
The experienced individual will have executive presence, excellent people management skills, advanced safety data review/analysis experience, superb written and verbal communication skills, as well as hands-on PV experience with a proven track record of major accomplishments.
• Direction and oversight of the Safety Science group;
• Ensuring effective BPV leadership of cross-functional Safety Management Teams;
• Ensuring high quality Safety Science support for WWRD;
• Ensuring quality authorship of required aggregate safety reports and core safety information for BioMarin products;
• Providing medical expertise for BPV;
• Ensuring quality authorship of Risk Management Plans (RMP);
• Authorship of responses to regulatory authority safety-specific inquiries;
• Authoring and/or providing input to PV policies and standard operating procedures;
• Coordinating BPV contributions to marketing authorization applications;
• Providing senior level PV representation on product-specific and/or clinical study teams and governance committees; and
• Mentoring and coaching Safety Science staff.
- Degree in Medicine required (MD); Board Certification may vary
• A minimum of 10 years in a senior/advanced PV role within the pharmaceutical/biotechnology industry.
• 3-5 years’ experience managing other clinicians;
- Strong people management skills, willingness to help others
• Demonstrated track record of accomplishments with high visibility programs.
• BLA/MAA experience a plus (but not required).
• Experience and success interacting with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.
• Knowledge of pharmaceutical research and development, global PV regulations, and ICH and GxP requirements/guidelines.
• Excellent communication and influencing skills within the function (up and down) as well as cross-functional; success influencing executives and senior level scientific management as well as external representation of company.
• Experience with working in innovative and ground breaking therapies.
• Successful in navigating fast changing and ambigious envirnonments.
• Outstanding leadership qualities with technical and emotional intelligence.