.Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.Discover Impactful Work:This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This person is responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations. This person leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results.This person may act as a clinical/medical representative in meetings with external stakeholders (e.G. collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.G. vendors, consultants, etc.) and other external audiences as needed.A day in the Life:Provides medical content and leadership of the clinical studiesMedical Monitoring of clinical studiesEstablish and approve scientific methods underlying the design and implementation of clinical protocolsEnsure study subject safetyRegularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basisCollaborate with the study executive and independent safety committee when neededRepresent clinical research through membership on trial teams.Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trialsInterprets, summarizes and documents clinical data for regulatory documents (e.G. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.Collaborate with leading academic medical centersRecruit, guide and motivate clinical investigatorsEnsure study compliance by understanding and applying all relevant SOPs and GCPsParticipate in long range strategic planningEducationMD degree with specialization in Psychiatry/ Neurology is mandatoryDrug Development experience in the area of Psychiatry/ NeurologyDesirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine
