Senior Clinical Scientist, Neurology

Corcept Therapeutics•Redwood City, CA

4d•$170,550 - $201,000

About The Position

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.

Requirements

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
Advanced degree (PharmD, PhD, MD, MSN, DNP, MPH, PsyD) required
Experience working in a cross-functional team and familiarity with related disciplines (ie, clinical operations, biostatistics, safety, regulatory, etc)
Applicants must be currently authorized to work in the United States on a full-time basis.

Nice To Haves

2+ years clinical development experience in industry strongly preferred

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