Director, Clinical Development, US

CK Group; London; Remote; USD 200,000 - 300,000; Full time

Job summary

A leading biotechnology company is seeking a Physician Director, Clinical Development, to oversee the execution of its Phase III clinical development program for a liver disease treatment. This permanent position allows for remote work within the US and requires a board-certified MD with extensive experience in clinical trials and regulatory processes.

Benefits

Competitive salary and benefits package

Qualifications

• Experience in hepatology or internal medicine is required.
• Experience in Phase III clinical trial execution within biopharmaceutical industry.
• Knowledge of regulatory processes across agencies like FDA and EMA.

Responsibilities

• Lead clinical trial execution and medical monitoring for Phase III program.
• Prepare documents for regulatory authorities and ethics committees.
• Establish relationships with clinical opinion leaders and investigators.

Skills

Clinical trial execution

Medical monitoring

Data analysis

Regulatory submissions

Scientific presentations

Collaboration with CROs

Scientific data disclosure

Education

Board Certified MD or equivalent

Job description

View more categories View less categories Sector Other Responsibilities Strategy Position/Level Director Contract Type Permanent

CK Group is working with a well-backed biotechnology company developing a biological product for liver disease, soon entering Phase III clinical studies. They are hiring a Physician Director, Clinical Development, a permanent position that can be remotely based anywhere in the US.

RESPONSIBILITIES:

As Physician Director, Clinical Development, you will contribute to executing the Phase III clinical development program for the company's lead product. Key duties include:

• Clinical trial execution, medical monitoring, data analysis, and reporting for regulatory submissions or scientific presentations and publications.
• Playing an active role in planning, conducting, and evaluating ongoing clinical trials to ensure successful execution.
• Serving as Medical Monitor for assigned trials, reviewing emerging medical/safety data, and collaborating with external CRO partners.
• Supporting and managing the preparation of materials for trial-related clinical committees such as Data Monitoring Committees and Adjudication Committees.
• Contributing to the planning, authoring, and review of documents submitted to regulatory authorities and ethics committees (e.g., Protocols, CSRs, Investigator’s Brochure, DSURs, clinical briefing documents, BLA/MAA components).
• Contributing to scientific data disclosures, including slide presentations, posters, and publications.
• Developing relationships with external clinical opinion leaders, investigators, and consultants, and staying informed of industry activities.

QUALIFICATIONS:

Qualifications for the Physician Director, Clinical Development include:

• Board Certified MD or equivalent with relevant medical experience.
• Experience in hepatology or internal medicine.
• Experience in Phase III clinical trial execution and medical monitoring within the biopharmaceutical industry.
• Experience preparing documentation for BLA/NDA/MAA submissions.
• Knowledge of regulatory processes across agencies like FDA and EMA.

Demonstrated ability to author or oversee regulatory documents such as protocols, CSRs, and briefing packages.

BENEFITS:

Competitive salary and benefits package.

APPLY:

Applicants must have entitlement to work in the US. Please quote the job reference in all correspondence.

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