Director, Regulatory Affairs - Global Labeling
Gilead SciencesFull Time
Expert & Leadership (9+ years)
Candidates must possess a Ph.D. or other relevant doctorate and have at least 5 years of clinical or pharmaceutical industry experience. A minimum of 8 years of relevant diagnostic medical affairs experience is also required, along with a deep understanding of lab medicine. Demonstrated abilities in outcomes focus, problem-solving, and measurement orientation are essential, as is a deep curiosity and drive to solve complex problems, create impactful solutions, and work effectively in a matrix environment with strong collaboration and influencing skills.
The Senior Director will leverage deep knowledge of lab medicine, pathology, and the diagnostic industry to create strategic plans for improving diagnostic accuracy and availability globally. They will serve as the enterprise's lab medicine expert, supporting diagnostic integration into training, evidence generation planning, and global diagnostic key opinion leader engagement. Key responsibilities include developing global diagnostic accuracy and availability strategies, managing diagnostic guideline body submissions, providing input into companion diagnostic partner selection, and maintaining a cross-business unit view of lab testing adoption. The role also involves collecting and disseminating insights on diagnostic technology trends, guiding external expert selection, providing diagnostic training to Lilly teams, and ensuring the integration of best practices across business units for diagnostic-relevant studies and research.
Develops and delivers prescription medicines globally
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.