Director Clinical Development US
Director Clinical Development US
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
RESPONSIBILITIES:
As Physician Director, Clinical Development you will contribute to the of the Phase III clinical development programme for the company s lead product. Key duties include clinical trial , medical monitoring, data analysis and reporting of results for regulatory submissions or scientific presentations and publications.
Key duties will include:
- Playing an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful
- Serving as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical/safety data and working closely with external CRO partners
- Supporting and managing the preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjudication Committees, etc.
- Contribution 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)
- Contribution to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications)
- Developing professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities
QUALIFICATIONS:
As Physician Director, Clinical Development you will require:
- Board Certified MD or equivalent with relevant medical experience
- Experience in hepatology or internal medicine
- Direct experience of Phase III clinical trial and medical monitoring gained in the biopharmaceutical industry
- Experience with preparation of documentation for BLA/NDA/MAA submissions
- Knowledge of the regulatory path across the various health authorities (FDA, EMA etc)
- Demonstrated ability to author or oversee regulatory documents (e.g protocols, CSRs, briefing packages)
BENEFITS:
Excellent salary and benefits package.
APPLY:
It is essential that applicants hold entitlement to work in the US. Please quote job reference 135 880 in all correspondence.
Employment Type
Remote
