Senior Medical Director, Therapeutic Area Safety Physician - Oncology and Neurology

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . The Senior Medical Director, Therapeutic Area Safety Physician provides senior medical safety leadership within assigned therapeutic areas for clinical development program(s) and, as applicable, post-marketing pharmacovigilance activities. Reporting to the Lead Medical Safety Physician, this role provides strategic medical oversight of safety surveillance, safety analyses, emerging safety issues, and benefit–risk assessment. The role partners closely with Safety Science, Clinical Development, Medical Affairs, Regulatory, Safety Operations, and Medical Review to ensure integrated, medically sound assessment of safety information and appropriate incorporation of safety considerations into development and lifecycle decisions. The role serves as a senior medical safety leader for assigned therapeutic areas and programs, providing medical leadership for safety strategy, benefit-risk assessment, governance activities, and cross-functional decision-making throughout the product lifecycle. Responsibilities: Therapeutic Area Medical Safety Leadership • Serve as the senior Medical Safety Physician for assigned therapeutic areas, providing medical safety leadership across clinical development and post-marketing activities • Develop and execute medical safety strategies aligned with program development plans, product lifecycle objectives, and applicable regulatory requirements • Provide independent medical assessment of emerging safety information, potential risks, and evolving benefit–risk considerations • Identify and proactively communicate important safety issues, trends, and emerging risks to appropriate governance bodies and senior leadership • Ensure appropriate escalation of significant or potentially significant safety concerns to the Lead Medical Safety Physician and relevant safety governance forums Signal Evaluation & Surveillance • Lead or contribute to signal detection, validation, evaluation, and ongoing safety surveillance for assigned products and therapeutic areas in partnership with Safety Science • Evaluate cumulative and emerging safety data from clinical trials, post-marketing sources, literature, epidemiologic data, and other relevant sources • Provide medical input into safety topics, emerging risks, and potential signals, including assessment of clinical relevance and implications for patient safety • Ensure appropriate documentation and communication of medical safety conclusions and recommendations Benefit–Risk Assessment & Risk Management • Lead medical safety input into ongoing benefit–risk assessments for assigned programs • Provide safety expertise for development decisions, including protocol design, eligibility criteria, monitoring strategies, dose selection, and risk mitigation approaches • Provide medical safety input into Risk Management Plans, risk minimization strategies, safety specifications, and other risk-management activities as applicable • Ensure safety risks and mitigation strategies are appropriately reflected in protocols, Investigator’s Brochures, Clinical Study Reports, regula