Negotiable
CK Group are recruiting for a Medical Director to join a highly respected consultancy working with clients on a global basis to help develop and commercialise new medicines.
The Role:
As Medical Director you will provide clinical and medical expertise to clinical development programs, clinical trials, regulatory strategy and medical affairs- for our global clients. In this role you will serve as a strategic advisor providing expert guidance on clinical strategy, medical governance, and innovation, helping clients navigate international markets and develop safe, effective, and compliant healthcare solutions.
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.
- 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.
- Competitive with an excellent benefits package
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence.
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INDCP
Negotiable