Physician Director, Clinical Development

CK Group; United States; Remote; USD 204,000 - 255,000; Full time

Job summary

A leading biotechnology company is seeking a Physician Director of Clinical Development to oversee their Phase III clinical development program aimed at liver disease. This permanent position offers the flexibility to work remotely anywhere in the US and involves responsibilities like clinical trial execution and regulatory documentation preparation. Ideal candidates will possess a Board Certified MD and have significant experience in biotechnology.

Benefits

Excellent salary and benefits package

Qualifications

• Board Certified MD with relevant medical experience.
• Experience in hepatology or internal medicine.
• Direct experience of Phase III clinical trial execution.

Responsibilities

• Contribute to execution of Phase III clinical trials.
• Serve as Medical Monitor for assigned clinical trials.
• Prepare documents for regulatory submissions.

Skills

Clinical Trial Execution

Medical Monitoring

Data Analysis

Regulatory Submissions

Education

Board Certified MD

Job description

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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 biotechnology sector
• 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 135880 in all correspondence.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science and Research

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