Clinical Development Director – Hepatology
GSK
full-time
Posted on:
Location Type: Office
Location: Boston • Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $202,500 - $337,500 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Provide clinical and scientific insights and leadership to clinical and translational studies
- Develop sections of core regulatory documents
- Generate data and evidence required to determine a target or medicine’s potential efficacy, safety profile, and key areas of product differentiation
- Define and deliver clinical development and study timelines and endpoints
- Collaborate with cross-functional teams and maintain relationships with program counterparts in various departments
- Contribute to strategic initiatives and organizational initiatives in Clinical Development
Requirements
- PhD or PharmD (or equivalent) degree required
- Experience in clinical research and development (may include postgrad experience)
- Knowledge of and experience in the execution of translational studies including both generation and analysis of human translational data and 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
- Experience working with global regulatory agencies and managing global clinical trials in hepatology
- Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchtranslational studiesdata generationdata analysispreclinical experimentsclinical developmentstudy timelinesendpoint definitionregulatory document developmentglobal clinical trials
Soft skills
leadershipcollaborationrelationship managementstrategic initiative contributionorganizational initiative contribution
Certifications
PhDPharmDGood Clinical Practice (GCP)