Director, Clinical Development, US

CK Group are working with a very well backed biotechnology company with a biological product for liver disease soon to be entering Phase III clinical studies. To support these they are hiring a Physician Director, Clinical Development, this will be a permanent position and can be remotely based, anywhere in the US.

RESPONSIBILITIES:

As Physician Director, Clinical Development you will contribute to the execution of the Phase III clinical development programme for the company s lead product. Key duties include clinical trial execution, 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 execution
• 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 execution 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 in all correspondence.