Medical Director - Gene Therapy - Remote
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.
You’ll be doing:
- Provides Medical and Safety monitoring on projects
- Provides expert advice and detailed clinical development strategies for allocated project, 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.
- For clinical operations success:
- Liaises and identifies suitable Key Opinion Leader via professional network or feasibility assessment.
- Provides scientific & medical support and guidance to the operational teams in all relevant aspects of Premier Research projects.
- Offers medical monitoring and/or drug safety support when appropriate and requested.
- Reviews Medical/Scientific Data as requested from Premier Departments e.g. CTM, Biometrics.
- 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.
- Ensures appropriate and timely communication with the relevant members of the project team and departments to maximize operational efficiency.
- Reviews documents produced by Medical Writing department and provide feedback and comments as needed.
- For commercial success:
- 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.
- Provides coverage for other colleagues within Medical Affairs if needed.
- Provide 24/7 medical coverage as needed
- Maintains current knowledge and overall awareness in the primary field of interest, clinical development in general, and the assigned therapeutic area.
- Mentoring and training of Premier Research staff.
- Participates in corporate initiatives and actions that ensure the continued success of the company
- Responsibilities of Line Manager for other Medical Directors
- Other activities as required or requested by Line Manager.
- Degree of Medicine
- Board certification/equivalent in a relevant therapeutic area is an advantage.
- Clinical/Clinical Research experience is an advantage.
- Previous experience of working in a CRO environment is a plus.
- Expert level of knowledge in the main field of interest and/or assigned therapeutic area, together with a thorough working knowledge in pharmaceutical medicine or medical device fields, clinical development, GCP and regulations pertinent to clinical research.
- Good business acumen within the CRO and drug development environment.