Director /Sr. Director - Clinical Development
A
Akero TherapeuticsBiopharmaceutical
RemoteFull-TimeDirector
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum of 3 years of relevant experience, five (5) years preferred
- Required Skills
- Excel VBAGCPMicrosoft ExcelMicrosoft OfficePowerPoint
Requirements
- Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience
- Experience in hepatology, MASH or internal medicine preferred
- Minimum of 3 years of relevant experience in clinical development in the biotech and/or pharmaceutical industry; five (5) years preferred
- Direct experience in executing Phase III clinical trials, including medical monitoring responsibilities
- Solid knowledge of GCP, ICH guidelines and FDA/EMA/CHMP regulations, with the ability to apply these principles and standards to ensure GCP-compliant trials
- Proven experience authoring or overseeing regulatory documents, including protocols, clinical study reports (CSRs) and briefing packages
- Strong interpersonal and communication skills, with a proactive, collaborative approach
- Skilled at searching, critically evaluating, interpreting and synthesizing scientific literature and clinical trial data
- Demonstrated problem-solving ability and ownership of issues to drive timely resolution; adaptable, detail-focused, and effective under time and resource constraints
- Comfortable working independently and as part of cross-functional teams, including engagement with external vendors
- Highly organized with strong prioritization and time-management skills; able to manage multiple projects concurrently
- Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint)
- 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
Responsibilities
- Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
- Serve as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical/safety data and working closely with external CRO partners
- Support/manage preparation of materials for trial-related clinical committees suchs 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, Investigator’s Brochure, DSURs, clinical briefing documents, components of BLA/MAA submissions)
- Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications)
- Develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities
- Contribute to engagement with external stakeholders such as vendor 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 development at internal cross-functional or external meetings
- Other duties related to clinical development of EFX as assigned
View Full Description & ApplyYou'll be redirected to the employer's site
