Medical Director I
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Medical Director to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
The Medical Director:
- 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
- Graduate in medicine with a focus in Internal Medicine (Board certification required)
- Ideally, previous clinical practice experience in Internal Medicine (Gastro-intestinal and Hepatic practice is preferred) along with at least 5 Years of previous CRO/pharma experience
- 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