Best suited to experienced medical professionals with a focus on endocrinology and metabolic diseases, working in a collaborative, cross-functional pharmaceutical development setting.
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Original posting from Corcept Therapeutics
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, 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 programs
Establish strong, constructive partnerships with Clinical Development, Medical Affairs, Regulatory, Clinical Operations, Biostatistics, Data Management, and other functions
Integrate safety insights into broader therapeutic area and asset strategies while maintaining independent medical safety judgment
Represent Medical Safety in program team meetings, development governance forums, and cross-functional decision-making
Partner 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 reports
Provide medical input for responses to health authority safety questions and participate in regulatory interactions as appropriate
Provide medical safety leadership within product- or program-level safety governance activities, including evaluation of emerging safety issues, benefit-risk assessments, and safety-related development decisions
Ensure safety decisions are appropriately documented, supported by available evidence, and escalated when necessary
Support 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 professionals
Where applicable, directly manage Medical Safety Physicians and contribute to performance management, talent development, and succession planning
Serve as a senior medical safety resource and subject matter expert
Contribute to the development and implementation of Medical Safety standards, operating procedures, training programs, and quality initiatives
Promote consistency and high-quality medical safety practices across therapeutic areas while identifying opportunities for continuous improvement
Partner 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 leadership
Strong clinical and scientific judgment
Benefit-risk and medical decision-making
Signal evaluation and safety surveillance
Cross-functional influence and collaboration
Strategic thinking and execution
Leadership, mentoring, and talent development
Clear, concise, and effective communication
Ability to operate effectively in a fast-paced, evolving environment
Preferred Education and Experience:
MD or equivalent medical degree required; board certification preferred
10+ years of relevant experience in the biotechnology or pharmaceutical industry, including substantial experience in pharmacovigilance, drug safety, or medical safety
Extensive experience providing strategic medical safety oversight across clinical development and/or post-marketing programs
Strong experience in medical case review, signal evaluation, safety surveillance, and benefit–risk assessment
Demonstrated experience providing medical safety leadership within one or more therapeutic areas and working with cross-functional development teams
Demonstrated experience supporting NDA and/or MAA filings, including development of safety content and responses to regulatory questions
Strong understanding of global pharmacovigilance regulations and safety requirements
Experience contributing to regulatory submissions and health authority interactions
Demonstrated leadership, mentoring, and/or people management experience
Ability to exercise independent medical judgment while operating effectively within a highly collaborative, matrixed organization
Experience 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.
Source: Corcept Therapeutics careers