Strategic Leader, Early Clinical Pharmacology Studies

Bristol Myers Squibb; Denham; On-site; GBP 90,000 - 140,000; Full time

Job summary

Bristol Myers Squibb in the United Kingdom is seeking a Senior Manager, Early Clinical Development, Clinical Pharmacology Studies to lead the design and oversight of early development programs. You will work at the heart of clinical pharmacology, crafting protocols, reviewing data, and contributing to regulatory submissions.

You will collaborate with cross-functional teams, drive data integrity, and develop training materials for study sites.

Qualifications

• Holds a degree in Life Sciences and has 2+ years of experience in early drug development focused in clinical pharmacology.
• Proficient knowledge of GCP/ICH, early development clinical pharmacology, study designs, statistics, clinical operations.
• Strong medical writing skills and ability to translate complex science into clear documents.

Responsibilities

• Crafting the blueprint – Developing and refining protocols and ICF documents, presenting them to governance committees, and ensuring every detail supports the science
• Protecting data integrity – Collaborating with data management to design data-focused eCRFs and contribute to Data Review Plans that are effective
• Authoring and reviewing clinical study reports and contributing to regulatory submissions (INDs, IBs, DSURs, etc)
• Raising the bar on-site – Building training materials and presenting at site initiation visits and investigator meetings so study sites are equipped to deliver high-quality data
• Keeping a finger on the pulse – Ongoing monitoring/review for clinical trends to ensure the safety of our study participants

Skills

GCP/ICH knowledge

Medical writing

Data review

Cross-functional collaboration

Regulatory submissions support

Education

Life Sciences degree (MD, PhD, PharmD, MS, RN, or equivalent)

Job description

Bristol Myers Squibb in the United Kingdom is seeking a Senior Manager, Early Clinical Development, Clinical Pharmacology Studies to lead the design and oversight of early development programs. You will work at the heart of clinical pharmacology, crafting protocols, reviewing data, and contributing to regulatory submissions.

You will collaborate with cross-functional teams, drive data integrity, and develop training materials for study sites.