Back to search
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.
If this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.
INDCP
