Provide medical and scientific expertise and leadership as a translational medicine expert (TME)
Drive success of early global programs and develop/implement strategies to transition to late-stage development
Drive success of late global programs by developing and implementing strategies for clinical pharmacology and profiling packages to meet regulatory requirements
Support translational research to develop 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
Report to the Dermatology TM Head and collaborate with other TMEs in Translational Medicine Discovery & Profiling (TMDP)
Lead global cross-functional project teams through early clinical phases (Phase I/IIa) and Ph2-3 profiling
Provide support for dose selection, study design and other clinical pharmacology matters throughout development
Oversee conduct and interpretation of studies to support pivotal trials and drive analysis of study results
Write TM portions of documents needed for regulatory submission and drug registration
Participate in BD&L teams as the TM representative and act as subject matter expert for disease indication and molecule
Responsible for clinical monitoring and integrated safety data review during and after live phases of studies
Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders
Oversee publication strategy for TM studies; lead writing of scientific publications and external presentations
Lead study-specific teams/clinical trial teams in partnership with other line functions to ensure operational excellence, timelines, costs, and subject burden balance with scientific standards
Requirements
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 independently as 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
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)
Benefits
Your compensation will include a performance-based cash incentive
depending on the level of the role, eligibility to be considered for annual equity awards
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits
a 401(k) with company contribution and match
a variety of other benefits
generous time off package including vacation, personal days, holidays and other leaves
Applicant Tracking System Keywords
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