Principal Clinical Scientist – Clinical Development
Akero Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $148,290 - $259,510 per year
Job Level
About the role
- Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
- Support medical monitoring activities for ongoing clinical trials.
- Support/manage preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjucation Committees, etc.
- Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (e.g., Protocols, CSRs, IB, clinical briefing documents).
- Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications).
- Co-ordinate aggregate report preparation (e.g., DSURs, PSUSARs, ASR), and safety management plans (SMPs) in collaboration with external vendors
- Contribute to engagement with external stakeholders such as vendors, thought leaders or other groups as needed including being the primary liaison with assigned individuals or groups.
- Function as an independent member of the team and represent clinical research at internal cross-functional or external meetings.
- Other duties related to clinical development of EFX as assigned.
Requirements
- PhD, PharmD or other qualification with relevant professional experience, (e.g. RN, NP, PA)
- At least 5+ years of relevant experience in clinical development in the biopharmaceutical industry
- Direct experience of Phase 3 clinical trial execution and medical monitoring support
- Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
- Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable
- Experience in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trialsmedical monitoringdocumentation preparationregulatory submissionsdata disclosuresaggregate report preparationsafety management plansclinical developmentPhase 3 clinical trial executionbiopharmaceutical industry
Soft Skills
planningcritical reviewcoordinationengagementindependencecommunicationliaisoncollaborationevaluationexecution
Certifications
PhDPharmDRNNPPA