Senior Clinical Scientist, Neurology

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.