Medical Director - Ukraine
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as Oncology, Analgesia, CNS, Rare Diseases, Dermatology and Pediatric Research.
We’re looking for a talented and innovative Medical Director, Oncology to join our dynamic team! This role can be located in any EU - locations.
Working at Premier Research means being an individual - you will be recognised for your expertise and you will truly have an impact. You will be working in an aspiring and empowering environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
Your main responsibilities:
- Provides Medical and Safety monitoring on projects
- Provides expert advice and detailed clinical development strategies for allocated projects, including protocol development, study design, investigator brochure development, regulatory strategy and submission, and study execution strategies
- Liaises with both internal and external experts, as needed, to serve the best interest of the client and produce high quality clinical development programs and other deliverables
- Provides scientific & medical support and guidance to the operational teams in all relevant aspects of Premier Research projects
- Reviews medical/scientific data as requested from Premier Departments
- Provides consultation with project teams (and/or other senior personnel) to assist client management and communication
- Offers both general and therapeutic training, including preparation of training materials
- Provides expert input on RFP/RFI, including (but not limited to) therapeutic overview, executive summary, patient recruitment, strategy and protocol considerations and study execution strategy as needed
- Attends client meetings in conjunction with specific proposals or general capabilities presentations as needed
- Leverages strategic collaborations with clients to expand the relationship and the services offered by Premier Research
- Provides account managers and other relevant personnel with the scientific information and training if necessary so as to facilitate the interaction with targeted clients
- Contributes to the development of marketing materials of Premier Research
- Raises the profile and image of Premier Research within the Pharmaceutical and Medical Device industry by representing the company in scientific/industry meetings, present and chairing panel presentations, contributing to the publications on peer-reviewed scientific and industry journals.
- Maintains current knowledge and overall awareness in the primary field of interest, clinical development in general, and the assigned therapeutic area
- Mentors and trains Premier Research staff
- Participates in corporate initiatives and actions that ensure the continued success of the company
- May have line management responsibility for other Medical Directors
You'll need this to be considered:
- Graduate in medicine is a must (board certification or equivalent in Oncology required)
- Previous clinical experience in Oncology is preferred along with previous CRO/pharma experience
- Experience as Medical Director is required
- Knowledge of ICH / GCP regulations as well as FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Excellent team player, collaborative and able to build an effective team
- Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
- Excellent organizational and time-management skills, able to prioritize workload to meet deadlines
- Is customer service focused in approach to work both internally and externally
- Maintains a positive, results orientated work environment