Director, Clinical Development, US

CK Group; Chesterfield; On-site; GBP 90,000 - 130,000; Full time

Job summary

A leading biotechnology company is hiring a Director of Clinical Development based in Chesterfield. The role involves leading clinical trials for a product entering Phase III studies, requiring strong medical expertise and regulatory knowledge. Successful candidates will manage trial execution and document preparation, ensuring compliance with regulatory standards for submissions.

Benefits

Excellent salary and benefits package

Qualifications

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

Responsibilities

• Contribute to execution of Phase III clinical development programme.
• Serve as Medical Monitor for assigned clinical trials.
• Support preparation of regulatory documents and materials.

Skills

Clinical trial execution

Medical monitoring

Data analysis

Regulatory submissions

Patient monitoring

Relationship building

Education

Board Certified MD

Job description

Social network you want to login/join with:

Director, Clinical Development, US, Chesterfield

col-narrow-left

Client:

CK Group

Location:

Chesterfield, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

4fc2886b9cca

Job Views:

10

Posted:

22.06.2025

Expiry Date:

06.08.2025

col-wide

Job Description:

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 135 880 in all correspondence.