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Corcept Therapeutics · 4 months ago

Associate Medical Director/Medical Director, Endocrinology/Metabolism

Redwood City, California, United States

Full-time

Onsite

New Grad, Entry, Mid, Senior Level, Lead/Staff, Director/Executive

$240K/yr - $310K/yr

0+ years exp

Corcept Therapeutics is a leader in the research and development of cortisol modulators, focusing on innovative treatments for serious diseases. The Associate Medical Director/Medical Director will play a key role in the clinical development of cortisol modulators for conditions such as endogenous hypercortisolism and metabolic associated steatohepatitis.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Act as a clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs

Act to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee

Design, develop and implement clinical studies for the applicable drug candidate, from Phase 1 through Phase 4

Develop and give internal and external presentations as a subject matter expert for the therapeutic area

Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents

Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports

Interact with principal investigators and opinion leaders to facilitate clinical trials research

Participate in appropriate regulatory discussion and activities, including the filing of INDs, CTXs and NDA/MAAs, throughout the development cycle

Participate in clinical study report conceptualization, development and writing for global regulatory submissions

Participate in the development and review of publications

Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc

Play a key role in the analysis, interpretation and delivery of high quality clinical data

Prepare and monitor budgets in collaboration with clinical operations and R&D finance

Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs

Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question

Serve as a liaison to the commercial team on medical issues

Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial

Qualification

Clinical developmentMedical oversightEndocrinology expertiseRegulatory submissionsScientific knowledgeCommunicatorClinical trial managementBudget monitoringLeadership skillsCross-functional collaboration

Required