Senior Manager, Early Clinical Development, Clinical Pharmacology Studies

Responsibilities

• Design and execute clinical trials to move promising compounds from concept to patient care
• Develop and refine study protocols and informed consent documents (ICF)
• Author and review clinical study reports and contribute to regulatory submissions (INDs, IBs, DSURs)
• Collaborate with cross-functional teams, including data management, clinical operations, and Key Opinion Leaders
• Monitor clinical data trends and review clinical narratives to ensure patient safety
• Create training materials and present at Investigator Meetings and Site Initiation Visits
• Partner with data management to design Case Report Forms (CRFs) and Data Review Plans

Requirements

• Degree in Life Sciences (MD, PhD, PharmD, MS, RN or equivalent)
• 2+ years of experience in early drug development, clinical pharmacology, or clinical research
• Strong knowledge of GCP/ICH guidelines and clinical study design
• Excellent medical writing skills with the ability to translate complex science into clear documents
• Proficiency in Microsoft Office and data review platforms

About the Company

Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We focus on developing medicines for serious diseases, including immunology, where we tackle conditions that significantly impact quality of life. At BMS, we foster a collaborative culture that empowers high-achieving teams to drive meaningful scientific breakthroughs.