Senior Manager, Early Clinical Pharmacology Studies

Bristol-Myers Squibb; Uxbridge; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Manager, Early Clinical Development, Clinical Pharmacology Studies to lead design and oversight of early clinical pharmacology studies. You will craft protocols, review data, and contribute to regulatory submissions, shaping medicines from concept to patients.

The role requires 2+ years in early development, strong medical writing skills, and the ability to work across cross-functional teams in a hybrid, globally connected environment.

Qualifications

• Hold a Life Sciences degree (MD, PhD, PharmD, MS, RN, or equivalent) and bring 2+ years of experience in early drug development focused in clinical pharmacology.
• Author/review clinical contributions to clinical study reports and clinical portions of regulatory documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contributions to regulatory submissions).
• Proficient knowledge of GCP/ICH, early drug development clinical pharmacology, study designs, statistics, clinical operations, etc.
• Can identify things others miss and you care about getting it right.
• Are comfortable navigating ambiguity - shifting priorities do not throw you, they energise you.
• Bring solid medical writing skills and translate complex science into clear, compelling 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
• Telling the scientific story – Authoring and reviewing clinical study reports and contributing to regulatory submissions (INDs, IBs, DSURs, etc) which open doors to health authorities
• 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 and proper care for study participants
• 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

Attention to detail

Communication skills

Education

Life Sciences degree (MD/PhD/PharmD/MS/RN)

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Bristol Myers Squibb is seeking a Senior Manager, Early Clinical Development, Clinical Pharmacology Studies to lead design and oversight of early clinical pharmacology studies. You will craft protocols, review data, and contribute to regulatory submissions, shaping medicines from concept to patients.

The role requires 2+ years in early development, strong medical writing skills, and the ability to work across cross-functional teams in a hybrid, globally connected environment.