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.

• Supports Development Team strategy and deliverables. Provides input on scope, complexity and size, and influence the budget of all aspects of a clinical program. Provides continual critical evaluation of the development/termination strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
• Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development or modification of development plans or study designs that may have a significant impact on timelines or study efficiency.
• Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to clinical development team involved in these activities and is accountable for the successful design and interpretation of clinical studies.
• Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance.
• Involved in communications with study site personnel as needed to support and address medical concerns or questions raised by study site personnel.

• MD, MB/BS or equivalent degree and strong medical knowledge
• Shown research clinical experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia

• Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
• Is fluent in spoken and written English
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
• Shown understanding of regulatory guidelines for adverse event reporting
• Strong communication & presentation skills and is a strong teammate