Senior Director Translational Medicine
Summary of Responsibilities
The Sr.Director Translational Medicine will contribute to the TMED group's mission of providing a strong scientific link between Discovery and Clinical research and Medical Affairs (CRMA) to develop an implement strategies which will enable Sunovion to make more rapid and effective decisions in Phase 1-3 clinical development of medicines to treat CNS disorders.
This position will play a key role in Sunovion's approach to utilizing an array of tools such as bioinformatics, biomarkers, in vivo imaging techniques and unique disease model development creating a more effective bridge between discovery research and clinical R&D,
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Research & Development
1. Collaborate with Experimental Medicine, Clinical Pharmacology, Modeling and Simulation and Program teams on approaches to define pharmacologic mechanisms of action and achieve sufficient clinical evidence of efficacy in humans to support the target and or compound for late stage development.
2. Interface with Clinical Operations, Biostatistics and Clinical Data Management as well as New Product Planning groups.
3. Present programs at internal review and strategy meetings
4. Attend scientific meetings , prepare manuscripts, and deliver presentations of scientific findings.
5 Define work processes to ensure flexible and highly efficient trial throughputs.
Minimum education requirements
5 - 7 Years
Knowledge & skills (general and technical)
MD required with significant clinical experience with either neuro degenerative,/ CNS / Mental health focus. Experience overseeing and conducting clinical trials strongly preferred
Other requirements (licenses, certifications, specialized training, physical or mental abilities required)
Proven ability to advance novel compounds from Phase I and beyond
Must possess strong quantitative and analytical skills along with exceptional interpersonal skills and the ability to function effectively in a cross-cultural environment.
Meaningful experience in the field of genetics
Demonstrated expertise in research as evidenced by a peer reviewed publications record, successful grant applications, etc.
Ability to recognize and exploit novel enabling technologies including but not exclusive to biomarkers, bioinformatics and in vivo imaging techniques.
Experience negotiating with FDA and other regulatory bodies.
Experience with patient reported outcomes and familiarity with digital health trends and developments.
Demonstrated ability to successfully challenge established practices and concepts. with the ability to support innovation, should it take one outside of their own comfort zone.
Demonstrated ability to successfully challenge established practices and concepts
All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a computer for extended periods of time.