Drive development of clinical plans and study designs and ensure alignment with translational plans and project strategies
Develop sections of core regulatory documents
Generate the data and evidence required to determine a target or medicines’ potential efficacy, safety profile
Deliver clinical development and study timelines and endpoints
Seek and maintain relationships with program counterparts across departments
Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives

Requirements

Medical Degree required; general internal medicine or alternative experience in a relevant disease area preferred
Completion of clinical residency and appropriate specialty training, ideally including hepatology experience
Experience in preclinical or clinical research and development (may include postgrad experience)
Knowledge and experience in the execution of translational studies including both generation and analysis of human translational data and/or conduct of preclinical biological experiments in relevant model systems
Robust knowledge of hepatology specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.

Benefits

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options
Annual bonus
Participation in share-based long-term incentive program

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical plans developmentstudy designregulatory document generationdata analysisclinical development timelinestranslational studies executionpreclinical researchbiological experimentshepatology knowledgeGood Clinical Practice (GCP)

Soft skills

relationship managementstrategic initiative implementationorganizational initiative contribution

Certifications

Medical Degreeclinical residency completionspecialty training