Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

A day in the Life:

• Provides medical content and leadership of the clinical studies
• Acts as therapeutic lead
• Medical Monitoring of clinical studies
• Establish and approve scientific methods underlying the design and implementation of clinical protocols
• Ensure study subject safety
• Regularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basis
• Collaborate with the study executive and independent safety committee when needed
• Represent 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 trials
• Interprets, 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 centers
• Recruit, guide and motivate clinical investigators
• Ensure study compliance by understanding and applying all relevant SOPs and GCPs
• Participate in long range strategic planning
• Line management responsibilities

Education

• MD degree, a minimum of 5 years of clinical drug development experience
• Drug Development experience in the area of Rheumatology

Knowledge, Skills, Abilities

• Demonstration and commitment to vigilant proactive problem solving
• Excellent leadership abilities
• Able 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.