Senior Director, Global Patient Safety Science

Responsibilities

• Responsible for safety surveillance and risk management activities including, but not limited to medical review of ICSRs, routine review of safety data, and pertinent scientific literature articles.
• Contribute to the review of assessments for safety signals or in response to Regulatory Authority requests.
• Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies.
• Plan and interpret safety data analyses, prepare and present safety data summaries to internal and external stakeholders.
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
• Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.
• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners) which require expert contribution to the development of the product safety strategy.
• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.
• Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.).
• Developing response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties.
• Drives risk minimization strategies and takes accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant.
• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR/PBRER, PADER) and other regulatory documents.
• Participate in internal and external Data Monitoring Committees through review of safety data, insights and leadership and development of DMC Charters.
• Lead representative for Safety Science during Health Authority meetings.
• Reviews publications, including abstracts, manuscripts, and speaker presentations.
• Trains and mentors Safety Scientists.
• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.

Required Experience, Skills and Education

• 10 or more years of drug development experience in the pharmaceutical or related industry, of which at least 6 years include prior Safety Science experience, which includes performance of medical review, safety surveillance/signal detection, and other related risk management activities.
• A relevant postgraduate qualification (e.g., MD, PharmD, PhD/MSc in a Life sciences discipline, or other post-graduate health professional qualifications).
• Mentor and lead a high-performing Safety Science team.
• Excellent ability to evaluate, interpret and present scientific data with clarity.
• Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
• Experience with interacting and leading with Regulatory Authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.
• Strong analytical and strategic thinking, problem-solving, and decision-making skills.
• Excellent communication, collaboration, and team management abilities.
• Extensive understanding of pharmacovigilance and risk management.
• Strong clinical leadership and experience.
• Outstanding emotional intelligence.

Preferred Skills

• Demonstrated ability to lead and influence in a global matrix environment.
• 4+ years of experience in Oncology clinical development.
• Proficiency in managing regulatory interactions, BLA/MAA experience.
• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.
• Excellent influence and collaboration/teamwork capabilities.
• Strong interpersonal and communication (written and verbal) skills.