Senior Clinical Scientist, Neurology
1 week ago
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.
The Senior Clinical Scientist will ensure the clinical and scientific integrity of clinical trials conducted by Corcept with guidance in the neurology therapeutic area.
Responsibilities:
- With guidance, 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
- With guidance, contribute to the design and execution of Phase 1-3 clinical trials for the assigned therapeutic programs
- Develop clinical and scientific content for inclusion into the clinical development plan for assigned therapeutic programs
- Collaborate in the writing and review of protocols/amendments, study-level consent forms, study plans, investigator brochures, study reports, ethics committee responses, and other clinical and regulatory documents
- Contribute to the creation of case report forms, training materials and provision of protocol/therapeutic area training to members of the clinical study team and investigative site staff
- Interact with principal investigators and opinion leaders to facilitate clinical trials research
- With guidance, develop content for clinical presentations and present to internal and external stakeholders (i.e., clinical development team meetings, advisory board meetings, investigator meetings, etc.)
- With oversight, contribute to safety monitoring for ongoing clinical trials, including participation in SAE reporting, review of safety data for emerging trends, and participation in study-level safety committee
- Play a key role in review, cleaning, analysis, interpretation, and delivery of high-quality clinical data
- With guidance, participate in appropriate regulatory discussion and activities, including the filing of INDs, CTXs, NDA/MAAs, throughout the development cycle
- Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, clinical pharmacology, medical writing, medical affairs, and commercial
- Participate in the development and review of publications
Preferred Skills, Qualifications and Technical Proficiencies:
- Strong clinical and scientific knowledge
- Working knowledge of applicable clinical trial regulations/guidelines (ie, ICH, FDA, EMA guidelines) and good clinical practice (GCP)
- Excellent communicator with strong interpersonal skills; ability to efficiently address conflict and build relationships with key partners and stakeholders
- Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities
Preferred Education and Experience:
- Advanced degree (PharmD, PhD, MD, MSN, DNP, MPH, PsyD) required
- 2+ years clinical development experience in industry strongly preferred
- Experience working in a cross-functional team and familiarity with related disciplines (ie, clinical operations, biostatistics, safety, regulatory, etc)
The pay range that the Company reasonably expects to pay for this headquarters-based position is $170,550 - $201,000; 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.
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:
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.
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