- Vacancy: Medical Director (Our Ref: MD_2018_02), Location: Bracknell, UK
- £Competitive + bonus + pension + company benefit platform
We are seeking a Medical Director to provide clinical leadership to the company’s clinical development team in support of our ongoing and emerging trials in the field of imaging diagnostics and radionuclide therapy in oncology. Will be responsible for medical strategic input for all clinical deliverables. The successful candidate will initially be engaged in establishing and managing Phase II and III trials, a strategic leader with the ability to participate in all aspects of the clinical development.
The role is based in our Head Office in Bracknell and travel will be required across the UK, Europe and US.
• Lead trial design, develop, review and revise IND/CTA documents, protocols, IB, CRF, ICF, IRB/EC documents, SAP, CSR and NDA documents
• Lead and implement the clinical development and registration strategy for the company’s diverse oncology pipeline, especially for US and EU markets
• Provide overall medical and safety oversight of the company’s oncology clinical trials as assigned, performing the duties of a Medical Monitor, if required.
• Act as a key driver to assigned clinical projects, provide medical and scientific expertise to project teams, participate in project feasibility and risk assessment
• Prepare clinical training slides for investigator meetings, participate and present in investigator meetings
• Provide oversight of CRO outsourced services to include; medical and safety monitoring, review clinical lab values, AEs, coding dictionaries and data tables, listings and figure
• Manages data safety monitoring board activities and scientific integrity of clinical trials
• Liaise with vendors on clinical trials.
• Interact with inter-departmental and external consultants, KOLs, and regulatory agencies as appropriate
• MD or equivalent medical degree from an accredited medical school recognised by the GMC (UK) or equivalent
• Five years of clinical development experience
• Experienced Medical Monitor
• Medical or Clinical Oncologist preferred.
• Experience in writing clinical development plans
• Experience in writing of Phase III clinical protocols, IB and study reports preferred
• Demonstrated ability to lead and work on multiple complex tasks and projects
• Outstanding presentation and communication skills, both written and oral
• Proven ability in communicating with both medical audiences and commercial investors
• Forward Thinking/Innovative
• Evidence of good interpersonal skills/patient centric
• Knowledge of Nuclear Medicine
• Experience in clinical trials in prostate cancer
• Experience in managing Regulatory submissions to FDA/EMA
• Financial management/budget control of projects
Part time applicants will be considered
To apply please visit emedcareers