Corcept Therapeutics
Associate Medical Director/Medical Director, Endocrinology/Metabolism
Corcept Therapeutics, Redwood City, California, United States, 94061
Associate Medical Director/Medical Director, Endocrinology/Metabolism
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. 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 Preferred Skills, Qualifications and Technical Proficiencies:
Demonstrate strong clinical and scientific knowledge Are an excellent communicator with proven leadership skills and the ability to interact in a cross functional environment Feel comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities Preferred Education and Experience:
MD, PharmD, or PhD with experience in Internal Medicine, Metabolic disease (e.g. MASH, Type 2 diabetes) or Endocrinology preferable 0-3 years of relevant clinical development experience Industry experience and experience medical monitoring is preferable The pay range that the Company reasonably expects to pay for this headquarters-based position is $240,000 - $310,000; 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.
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. 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 Preferred Skills, Qualifications and Technical Proficiencies:
Demonstrate strong clinical and scientific knowledge Are an excellent communicator with proven leadership skills and the ability to interact in a cross functional environment Feel comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities Preferred Education and Experience:
MD, PharmD, or PhD with experience in Internal Medicine, Metabolic disease (e.g. MASH, Type 2 diabetes) or Endocrinology preferable 0-3 years of relevant clinical development experience Industry experience and experience medical monitoring is preferable The pay range that the Company reasonably expects to pay for this headquarters-based position is $240,000 - $310,000; 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.