AssociateDirector Translational Medicine Expert (Discovery)
AssociateDirector Translational Medicine Expert (Discovery)
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Job Description
Job Description Summary
As a translational medicine expert (TME) you provide medical and scientific expertise and leadership to:Drive success of early global programs develop and implement strategies to transition to late-stage development.
Drive success of late global programs by developing and implementing strategies which lead to clinical pharmacology and profiling packages that meet regulatory requirements and support differentiated and competitive drug labeling.
Support translational research in developing new indications endpoints and biomarkers using in vitro in vivo or in silico methods.
Provide scientific expert assessments and support for in-licensing opportunities including due diligence
Job Description
This hybrid role can be based in Basel Switzerland or London United Kingdom.
About the role:
As a Dermatology TME you will report to the Dermatology TM Head and collaborate with other experienced TMEs in Translational Medicine Discovery & Profiling (TMDP) to develop high value decision-strategies for the Translational Medicine component of drug development projects and lead global cross-functional project teams through the early clinical phase.
Job Description
Key Responsibilities:
Early clinicalprojects(Phase I / II Discovery):
Develop in collaboration with other experienced TMEsand work with teams to carry outstrategies for the Translational Medicine component of drug development projectsfromresearch to late-stage transition insingleor multiple indications including indication expansion projects.
Lead global project teams through phase I/IIa to drive implementation of the development strategy.
Late-stage clinical projects(Profiling):
Act as a key leader in developing the Ph2-3 and post-approval profiling strategy for drug programs representing TMDP on Global Project Team (GPT) along with other TM line support for dose selectionstudydesign and other clinical pharmacology matters throughout the development cycle. Oversee conduct and interpretation of studiesprioritized by the to support the pivotal trials.
Driveanalysis of studies and presents results to relevant decision boards.
Be responsible forwriting TM portions ofdocuments needed forregulatorysubmissionthrough drug registration.
Translational Research (TR;indication seeking endpoint and biomarker development):
In collaboration with Dermatology TM HeadBR Research scientists other TM line functions (biomarker clinical operations preclinical safety and pharmacokinetics) develop strategies to identify initial or expansion (indications).
This may include methodology studies to identify and validate novel endpoints for earlydecision making inPhase IIastudies.
Business Development and Licensing (BD&L;in-licensingandout licensingcompounds):
Participate in BD&L teams as the TM representative.
Participate in teams carrying out licensingof programs as subject matter expert for the disease indication molecule and clinical trial experience.
General responsibilities:
Responsiblefor clinical monitoring and integrated safety data review during and after the live phase of a study.
Providesmedical and scientific leadership and expertise to all line functions on the study team.
Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders( patient advocacy groups).
Oversee publication strategy for TM studies; lead writing of scientific publications; present study results externally where appropriate.
Lead study-specific teams/ clinical trial teamsin partnership with other line functions and collaborate closely with other TM (especially clinical operations) and non-TM (especially Project Management) line functions to ensure operational excellence continued urgency and close attention to timelines costs and subject burden in balance with high scientific standards and innovation.
Essential Requirements:
This position will be located at the Cambridge MA London UK or Basel Switzerland site and will not have the ability to be located remotely.
This position will require approximately 7% travel as defined by the business (domestic and/ or international).
This is adualposting*. The final level and title of the offer role would be determined by the hiring team based on the skills experience and capabilities required to perform the role at the level the role has been offered (Associate Director / Director).
Doctoral degree MD required with clinical subspecialty training in dermatological diseases; Additional PhD/post-doctoral equivalent research and relevant Board certification preferred.
Associate Director Level: 1-2 years of experience in a pharmaceutical/biotech company CRO or academic medical center or related experience; Director Level: 5 years of experience in a pharmaceutical/biotech company CRO or academic medical center or related experience.
Recognized medical expertise as evidenced by publication of significant contributions to a field over time.
Excellent written and oral communication/presentation skills.
Independence: Able to work independentlyas outlined above commensurate with the level of the role.
Innovation: Seeks out new clinical discovery opportunities and approaches to accelerate programs.
Leadership of Collaborations: Able to lead multidisciplinary teams in a matrix organization.
Team player mentality and willingness to collaborate and interact with the other TMEs.
Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. to Diversity and Inclusion: Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here: Desired
Active Directory Artificial Intelligence (AI) Biostatistics Classification Systems Clinical Pharmacology Critical Thinking Customer Satisfaction Drug Discovery Electronic Components Lifesciences Medical Research Modeling And Simulation Patient Care Personalized Medicine Sales Selling Skills Translational MedicineRequired Experience:
Director
Employment Type
Full-Time
