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Corcept Therapeutics · 1 day ago

Senior Clinical Scientist, Neurology

Redwood City, California, United States

Full-time

Onsite

Mid, Senior Level

$171K/yr - $201K/yr

2+ years exp

Corcept Therapeutics is a leader in the research and development of cortisol modulators, focusing on innovative treatments for serious diseases. The Senior Clinical Scientist will ensure the clinical and scientific integrity of clinical trials in the neurology therapeutic area, contributing to the design, execution, and oversight of clinical studies.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Clinical trial designClinical development experienceRegulatory knowledgeScientific knowledgeGCP guidelinesCross-functional teamworkInterpersonal skillsCommunication skillsFast-paced adaptability

Preferred

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

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)