Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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:

Provides clear medical leadership in the Study team,  working  in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget.

A day in the Life:

Provide medical leadership  to the study teams , including creating clinical trial protocols while  implementing the latest scientific information, contribute to site selection ,  contribute to review and approval of  study protocols and  amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trialsReal time Medical Monitoring of clinical studies:   ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and correction  of issues  in consultation with the Global Medical Indication LeadInterpret the   clinical trial  data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication LeadMedical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities,  prepare and present material to   the study executive and independent safety committee if  applicable;  medical  training of site staff at Investigator meetings;  CRA training in new indicationsEnsure study compliance for all medical aspects  by understanding and applying all relevant SOPs and GCPClosely collaborate  with the cross functional study  team members in order for  medical  risks, issues, and results to be  clear to all involved partiesIn case more than 1 physician is working on the protocol , a primus inter pares will be appointed and he/she will ensure that  answers to questions  from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonised across medics  

Education and background:

Medical Doctor; relevant specialty education preferred ( e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine,  pediatric, )Some experience in industry preferredExcellent English, both written and spoken  is a must, as well as ability to travel.Proven  interpersonal skills enabling to lead a study  team,  while recognising individual expert competencies, providing  medical advice and evaluations exercising  judgement in which issues need to be escalated immediately  Pro-active problem solver with negotiation skills ,  remaining sensitive to the different  cultural needs in a global organisationStrong communication skills to ensure  close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. 

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.