Job Description

　　At 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. 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.

　　We have a client - dedicated and internal PPD positions currently open in the field of Neurology

　　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 planning

　　Education

　　MD degree with specialization in Neurology is mandatoryDrug Development experience in the area of NeurologyDesirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.

　　Knowledge, Skills, Abilities

　　Demonstration and commitment to vigilant proactive problem solvingExcellent leadership abilitiesAble to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.Previous experience with regulatory submissions.Excellent written and verbal communication skills.Ability to travel.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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