Global Safety Program Lead

Job Description

: Safety Expert: Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications. Accountable for the implementation and high-quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s). Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy. For the assigned asset(s), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging, and guidelines for toxicity management of the asset. Accountable for project representation for Global Patient Safety at governance and other forums where safety is involved. Accountable for the quality of key safety results e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance, and adherence to PV regulations of the assigned asset(s). Leads response to complex technical issues for specific safety aspects for the assigned asset(s). Accountable for safety contribution to study designs and study concept delivery within their assigned program. Provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of clinical programs for the assigned asset(s). Leads the safety physicians and scientists to support the safety strategy and input into program design, monitoring, data interpretation from pre-clinical and clinical studies, communication, post-marketing surveillance, epidemiology, pre-clinical literature, epidemiology for each asset. Ensures compliance with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards. Represents the Company and is accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves safety issues in the study team. May be required to support in-licensing opportunities. Encourages collaborative and proactive team actions and behaviors across functions. Accountable for implementation of new processes, systems, learning, including new ways of working. Prioritizes risk mitigation strategies and effective troubleshooting. Line manages a team of safety physicians and scientists Scientific clinical safety analytical accountabilities: Maintains up-to-date knowledge of relevant safety scientific literature and communicates key impactful information clearly. Accountable for proper data collection and interpretation to determine risks and inform labels in global markets. Delivers analyses of clinical safety data in a balanced and statistically robust manner to drive interpretations and develop novel proposals. Serves as a source of scientific and clinical safety knowledge for the Product Team in analyzing and interpreting scientific and clinical safety data. Essential Skills/Experience: Medical degree or experience in biomedicine or science 5 years extensive relevant clinical, safety, and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence on clinical studies/programs Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making (e.g., Clinical Development, Medical Affairs, Regulatory Affairs) Thorough knowledge and understanding of pharmacovigilance & safety results, standards, and processes at a global level; including pre and post-launch experience Experience with global regulatory submissions and interacting with major regulatory agencies Strong ability to successfully lead, coach, and mentor other safety medical directors/scientists Available to travel domestically and internationally Ability to present sophisticated topics to senior leaders at safety and development governances for alignment and endorsement Desirable Skills/Experience: PhD or equivalent experience (or other scientific field) Excellent independent judgment based on groundbreaking knowledge and expertise Excellent speaking skills; industry conference speaking experience Demonstrated clinical safety and research expertise in an appropriate disease area