Interim Medical Director

CK Group- Science, Clinical and Technical; Cambridge; On-site; GBP 200,000 +; Full time

Job summary

A respected consultancy in Cambridge seeks an experienced Interim Medical Director to advise clients on clinical development strategies and lead the medical input for projects. Candidates should have a medical degree and substantial experience in drug development. This role offers a competitive salary with an excellent benefits package.

Benefits

Excellent benefits package

Qualifications

• Substantial experience in drug development within a consultancy or advisory capacity.
• Expertise in developing clinical development plans.
• Medical input into regulatory strategies like IND NDA and MAAs.

Responsibilities

• Advise clients on clinical development strategies.
• Lead strategic medical input to client projects.
• Maintain oversight of patient safety in assigned studies.

Skills

Clinical development strategies

Medical governance frameworks

Global regulatory pathways

Scientific communications

Patient safety monitoring

Education

Medical Degree (MBBS, MBChB, MD)

GMC registration

Postgraduate qualifications in Pharmaceutical Medicine

Job description

CK Group are recruiting for an Interim Medical Director to join a highly respected consultancy working with clients on a global basis to help develop and commercialise new medicines.

Responsibilities

• Advise clients on clinical development strategies, medical governance frameworks, and global regulatory pathways.
• Lead strategic medical input to client projects and documents as required, e.g., project budgets, clinical development plans, target product profiles and due diligence support.
• Review and provide input into essential documents, e.g., IB, protocols, PIS/ICF, SAP, Safety/PVMPs, DMPs, CRFs and CSR.
• Act as an independent physician and medical monitor for an assigned study on behalf of the client, as per the ICH Guideline for Good Clinical Practice E6 (R2).
• Guide medical affairs teams in scientific communications. Advise on medical affairs strategy including KOL engagement, publication planning, and scientific communications.
• Contribute medical expertise by acting as the trial level physician and medical monitor to facilitate the set-up, execution, analysis and reporting the results of clinical trials in line with current regulatory and ethical guidelines.
• Maintain oversight of patient safety and safety monitoring in the assigned study, participate in Safety Review/DSMBs as required, and be a designated point of contact for the site team and sponsor on any safety-related matters as outlined in the MM and Safety Plans.

Your Background

• A Medical Degree (MBBS, MBChB, MD) and GMC registration, preferably with post graduate qualifications and Diploma in Pharmaceutical Medicine.
• Substantial experience in drug development ideally within a consultancy or advisory capacity.
• Expertise in developing and operationalizing clinical, designing clinical development plans. Medical input into regulatory strategies and processes, such as IND NDA and MAAs.

Salary & Apply

Salary: Competitive with an excellent benefits package

Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference in all correspondence.

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