Medical Director - Dermatology
Princeton , NJ 08540
Posted 3 weeks ago
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This position will have a major role in providing medical monitoring, therapeutic oversight to study programs and supporting Business Development activities aimed at winning new operational and providing input to consulting projects for TFS.
It will provide TFS clients with expert input into the design and implementation of clinical development programs of pharmaceutical products and medical devices in the field of interest and the assigned therapeutic area. This individual will also provide scientific, medical and strategic support to TFS team across all departments.
The Medical Director:
- 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.
ESSENTIAL JOB FUNCTIONS
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 TFS projects.
- Offers medical monitoring and/or drug safety support when appropriate and requested.
- Reviews Medical/Scientific Data as requested 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 TFS.
- 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 TFS.
- Raises the profile and image of TFS 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 TFS staff.
- Participates in corporate initiatives and actions that ensure the continued success of the company
- Other activities as required or requested by Line Manager.
- Board certification preferred
- At least 3 years experience in a medical department in clinical development in the pharmaceutical industry.
- At least 5 years of clinical experience.
- Previous experience of working in a CRO environment is a plus.
Expertise and know-how
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
to be discussed during hiring process