Clinical Pharmacology Lead – Early Development

Bristol-Myers Squibb Co

Uxbridge

Hybrid

GBP 70,000 - 120,000

Full time

9 days ago

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Job summary

Bristol Myers Squibb is seeking a Senior Manager, Early Clinical Development, Clinical Pharmacology Studies, to lead and oversee early clinical pharmacology studies from concept to patient. You will author and review protocols, data-focused reports, and regulatory submissions, while ensuring data integrity and participant safety across global sites.

The role involves cross-functional collaboration, international partner interaction, and travel of about 10–20%.

Qualifications

Hold a Life Sciences degree (MD/PhD/PharmD/MS/RN or equivalent) and 2+ years in early drug development focused in clinical pharmacology.
Author/review clinical contributions to study reports and regulatory documents (Pre‑IND, IND, IB, DSUR, PSUR, HA, EC, IRB).
Proficient knowledge of GCP/ICH, study designs, statistics, clinical operations and regulatory submissions.
Identify issues others may miss and strive for accuracy.
Comfortable navigating ambiguity and shifting priorities.
Strong medical writing skills translating complex science into clear documents.
Solid skills in Word/Excel/PowerPoint and data review tools.

Responsibilities

Craft protocols and ICF documents; present to governance committees to support science.
Collaborate with data management to design data-focused eCRFs and Data Review Plans.
Author/review clinical study reports and contribute to regulatory submissions.
Develop training materials and present at site initiation visits and investigator meetings.
Monitor emerging clinical trends to ensure participant safety.