Senior Clinical Scientist, Neurology

Role Summary

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

Qualifications

• Preferred: Strong clinical and scientific knowledge
• Preferred: Working knowledge of applicable clinical trial regulations/guidelines (ie, ICH, FDA, EMA guidelines) and good clinical practice (GCP)
• Preferred: Excellent communicator with strong interpersonal skills; ability to efficiently address conflict and build relationships with key partners and stakeholders
• Preferred: Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities

Education

• Preferred: Advanced degree (PharmD, PhD, MD, MSN, DNP, MPH, PsyD) required
• Preferred: 2+ years clinical development experience in industry strongly preferred
• Preferred: Experience working in a cross-functional team and familiarity with related disciplines (ie, clinical operations, biostatistics, safety, regulatory, etc)