Senior Manager, Early Clinical Pharmacology Studies

Bristol-Myers Squibb Co; Denham; Ibrido; GBP 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Bristol Myers Squibb is seeking a Senior Manager, Early Clinical Development, Clinical Pharmacology Studies to lead and oversee early development studies in clinical pharmacology.

You will craft protocols, review data, and contribute to regulatory submissions, partnering with internal and external teams to ensure scientific rigor and patient safety across phase 1/2a programmes. This role offers global collaboration and travel.

Competenze

• Hold a Life Sciences degree with 2+ years in early drug development focused in clinical pharmacology.
• Author/review contributions to clinical study reports and regulatory documents (INDs, IBs, DSURs, etc).
• Proficient knowledge of GCP/ICH, study designs, statistics, clinical operations.
• Can identify things others miss and care about getting it right.
• Comfortable navigating ambiguity and changing priorities.

Mansioni

• Crafting the blueprint – Developing and refining protocols and ICF documents, presenting them to governance committees and ensuring science supports the study.
• Protecting data integrity – Collaborating with data management to design data-focused eCRFs and Data Review Plans.
• Telling the scientific story – Authoring and reviewing clinical study reports and contributing to regulatory submissions.
• Raising the bar on-site – Building training materials and presenting at site initiation visits and investigator meetings.
• Keeping a finger on the pulse – Ongoing monitoring/review for clinical trends to ensure patient safety.

Conoscenze

GCP/ICH knowledge

Medical writing

Clinical study oversight

Cross-functional collaboration

Data review skills

Regulatory submissions

Formazione

Life Sciences degree

MD/PhD/PharmD/MS/RN equivalent

Descrizione del lavoro

Bristol Myers Squibb is seeking a Senior Manager, Early Clinical Development, Clinical Pharmacology Studies to lead and oversee early development studies in clinical pharmacology.

You will craft protocols, review data, and contribute to regulatory submissions, partnering with internal and external teams to ensure scientific rigor and patient safety across phase 1/2a programmes. This role offers global collaboration and travel.