Interim jobs in United States

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.

• 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.

• 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: 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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