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Clinical Scientist

Location
Cambridge, MA

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u003Cpu003Eu003Cspanu003Eu003Cspanu003Eu003Cstrongu003EPosition description: u003C/strongu003Eu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EThe primary responsibility of the Clinical Scientist, Clinical Research will be to provide medical expertise and leadership necessary to advance one or more of the Companyu2019s lead drug candidates through Phase I, II and III clinical trials. The Clinical Scientist/ Associate Director, Clinical Research, will drive the design, planning, and implementation of clinical program/s and study protocols for drugs that are in all phases of development, and will play a key role in supporting related regulatory activities. This clinical expert/scientist will also support attainment of corporate strategic objectives by contributing their clinical, scientific and development expertise to business development initiatives, co-development partnerships, and development plans for pre-clinical programs.u003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003Cpu003Eu003C/pu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003Eu003Cstrongu003EResponsibilities: u003C/strongu003Eu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003ELead/support the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategyu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EBe the recognized clinical expert for these development program/s both within and external to Ironwoodu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EProvide extensive medical and scientific input into the design of clinical trials for these development programsu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EServe as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budgetu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EAssist in the preparation of clinical study protocols and FDA/EMA documents (eg., INDs, annual reports, meeting requests, briefing books, and NDAs) and other relevant clinical documentsu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EProvide authoritative clinical leadership in preparation for and interactions with Regulatory Authoritiesu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EPlay a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I to III safety and efficacy trials; assist in generating the study reports and publications from these trialsu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EEstablish strong Scientific Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and study protocolsu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003ECollaborate with other members of the Clinical Affairs and broader Ru0026amp;D teams on medical matters related to drug developmentu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003ESupport pre-clinical development planning, patho-mechanistic insight and translational medicine efforts to effectively advance pipeline programsu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EProvide clinical, scientific and development expertise to business development initiatives as neededu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003C/ulu003Eu003Cpu003Eu003C/pu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003Eu003Cstrongu003EBasic qualifications:u003C/strongu003Eu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EAn MD or DO degree preferredu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EMedical expertise in internal medicine (specialty training and board certification, eligibility or expertise in gastroenterology].u003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003ERelevant pharmaceutical/biotech-industry experience in clinical research and development, and/or clinical/scientific consulting with substantial experience as an investigator in clinical trials ideal.u003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EDemonstrated expertise in evaluation and analysis of clinical/scientific data, ideally with successful publications thereof.u003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EGeneral knowledge of regulatory requirements such as apply to clinical drug developmentu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003C/ulu003Eu003Cpu003Eu003C/pu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003Eu003Cstrongu003EPreferred qualifications:u003C/strongu003Eu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EA PhD and/or translational medicine expertise a significant plus (not required)u003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EExcellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environmentu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EPersuasive, effective and flexible in personal interactions at all levels, with strong oral and written communication capabilitiesu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EStrong project management and problem-solving skillsu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003Cliu003Eu003Cpu003Eu003Cspanu003Eu003Cspanu003EDisplays sense of urgency, and a willingness to roll up sleeves to get the work doneu003C/spanu003Eu003C/spanu003Eu003C/pu003Eu003C/liu003Enu003C/ulu003E,datePosted:2018-08-11,employmentType:FULL_TIME,industry:Medical/Healthcare,hiringOrganization:{@type:Organization,name:Ironwood Pharmaceuticals},identifier:{@type:PropertyValue,name:Ironwood Pharmaceuticals,value:1575},jobLocation:{@type:Place,address:{@type:PostalAddress,addressCountry:US,streetAddress:,addressLocality:Cambridge,addressRegion:MA,postalCode:02138}}}

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