Clinical Scientist, Oncology
Corcept Therapeutics
Summary
The Clinical Scientist will ensure the clinical and scientific integrity of clinical trials conducted by Corcept in the Oncology therapeutic area.
Job description
Responsibilities
- Act as clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned 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
- Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs
- Collaborate 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
- Acts to provide clinical oversight and contributes to safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
- Play a key role in the analysis, interpretation and delivery of high-quality clinical data
- Interact with principal investigators and opinion leaders to facilitate clinical trials research
- Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
- Participate in clinical study report conceptualization, development and writing for global regulatory submissions
- Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
- Develop and give internal and external presentations as subject matter expert for the therapeutic area
- Participate in the development and review of publications
- Prepare and monitor budgets in collaboration with clinical operations and R&D finance
- Serve as liaison to the commercial team on scientific issues
Preferred Skills, Qualifications and Technical Proficiencies
- Strong clinical and scientific knowledge
- Excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
- Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities
Preferred Education and Experience
- Pharm D, PhD, MD or equivalent, preferably with experience in oncology therapeutic area(s)
- 0-2+ years of relevant clinical development experience is preferred
- Relevant clinical research experience in academic settings is desirable
Requirements
- Pharm D, PhD, MD or equivalent
- 0-2+ years of relevant clinical development experience
- Strong clinical and scientific knowledge
- Excellent communicator with proven leadership skills
- Ability to interact in a cross functional environment
- Comfortable in a fast-paced and nimble small company environment
- Able to adjust workload based upon changing priorities
- Experience in oncology therapeutic area(s) preferred
- Relevant clinical research experience in academic settings desirable
Company overview
Corcept Therapeutics Inc. is a commercial-stage pharmaceutical company founded in 1998 and headquartered in Redwood City, California. The company specializes in the discovery, development, and commercialization of medications that treat severe metabolic, oncologic, and neuropsychiatric disorders by modulating the effects of the hormone cortisol. Corcept's primary focus is on addressing the adverse effects of excess cortisol, which can lead to life-threatening conditions including Cushing's syndrome, various cancers, diabetes, and neurological disorders. The company's flagship product is Korlym (mifepristone), the first FDA-approved oral therapy for treating hyperglycemia in adult patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance. With approximately 500 employees, Corcept has developed a large portfolio of proprietary compounds that selectively modulate cortisol effects without compromising progesterone function. The company maintains extensive intellectual property covering its selective cortisol modulators and continues to advance clinical trials for potential treatments of hypercortisolism, advanced ovarian cancer, prostate cancer, ALS, and MASH.