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 activitiesDevelop and execute medical safety strategies aligned with program development plans, product lifecycle objectives, and applicable regulatory requirementsProvide independent medical assessment of emerging safety information, potential risks, and evolving benefit–risk considerationsIdentify and proactively communicate important safety issues, trends, and emerging risks to appropriate governance bodies and senior leadershipEnsure 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 ScienceEvaluate cumulative and emerging safety data from clinical trials, post-marketing sources, literature, epidemiologic data, and other relevant sourcesProvide medical input into safety topics, emerging risks, and potential signals, including assessment of clinical relevance and implications for patient safetyEnsure 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 programsProvide safety expertise for development decisions, including protocol design, eligibility criteria, monitoring strategies, dose selection, and risk mitigation approachesProvide medical safety input into Risk Management Plans, risk minimization strategies, safety specifications, and other risk-management activities as applicableEnsure safety risks and mitigation strategies are appropriately reflected in protocols, Investigator’s Brochures, Clinical Study Reports, regulatory submissions, and other relevant documents Cross-Functional Therapeutic Area Leadership Serve as the primary Medical Safety Physician partner to Clinical Development Therapeutic Area Medical Leads for assigned programsEstablish strong, constructive partnerships with Clinical Development, Medical Affairs, Regulatory, Clinical Operations, Biostatistics, Data Management, and other functionsIntegrate safety insights into broader therapeutic area and asset strategies while maintaining independent medical safety judgmentRepresent Medical Safety in program team meetings, development governance forums, and cross-functional decision-makingPartner with Medical Affairs to support medically accurate and consistent safety communication across internal and external materials Regulatory & Safety Governance Provide medical safety leadership and input into DSURs, PADERs/PBRERs, Clinical Evaluation Reports, safety sections of regulatory submissions, and other aggregate safety reportsProvide medical input for responses to health authority safety questions and participate in regulatory interactions as appropriateProvide medical safety leadership within product- or program-level safety governance activities, including evaluation of emerging safety issues, benefit-risk assessments, and safety-related development decisionsEnsure safety decisions are appropriately documented, supported by available evidence, and escalated when necessarySupport inspection and audit readiness and participate in health authority inspections or audits as appropriate Organization Leadership Provide leadership, coaching, and mentoring to Medical Safety Physicians and other safety professionalsWhere applicable, directly manage Medical Safety Physicians and contribute to performance management, talent development, and succession planningServe as a senior medical safety resource and subject matter expertContribute to the development and implementation of Medical Safety standards, operating procedures, training programs, and quality initiativesPromote consistency and high-quality medical safety practices across therapeutic areas while identifying opportunities for continuous improvementPartner with the Lead Medical Safety Physician on organizational scaling, resource planning, capability development, and strategic priorities Preferred Skills, Qualifications and Technical Proficiencies: Therapeutic area medical safety leadershipStrong clinical and scientific judgmentBenefit-risk and medical decision-makingSignal evaluation and safety surveillanceCross-functional influence and collaborationStrategic thinking and executionLeadership, mentoring, and talent developmentClear, concise, and effective communicationAbility to operate effectively in a fast-paced, evolving environment Preferred Education and Experience: MD or equivalent medical degree required; board certification preferred10+ years of relevant experience in the biotechnology or pharmaceutical industry, including substantial experience in pharmacovigilance, drug safety, or medical safetyExtensive experience providing strategic medical safety oversight across clinical development and/or post-marketing programsStrong experience in medical case review, signal evaluation, safety surveillance, and benefit–risk assessmentDemonstrated experience providing medical safety leadership within one or more therapeutic areas and working with cross-functional development teamsDemonstrated experience supporting NDA and/or MAA filings, including development of safety content and responses to regulatory questionsStrong understanding of global pharmacovigilance regulations and safety requirementsExperience contributing to regulatory submissions and health authority interactionsDemonstrated leadership, mentoring, and/or people management experienceAbility to exercise independent medical judgment while operating effectively within a highly collaborative, matrixed organizationExperience in a growing biotechnology or pharmaceutical organization preferred The pay range that the Company reasonably expects to pay for this headquarters-based position is $298,000- $350,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.