Senior Manager, Early Clinical Development, Clinical Pharmacology Studies

Bristol Myers Squibb; Denham; In loco; GBP 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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

Conoscenze

GCP/ICH knowledge

Medical writing

Data review

Cross-functional collaboration

Regulatory submissions support

Formazione

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

Descrizione del lavoro

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Job Description

What if your next role could change someone's life?

Not in a vague, corporate-speak kind of way. We mean genuinely, concretely, and measurably change the life of a patient who is waiting for a treatment that does not yet exist.

At Bristol Myers Squibb, that is not an aspiration, it is our work. And we are looking for someone like you to help make it happen.

This is your invitation to shape medicines from day one

As a Senior Manager, Early Clinical Development, Clinical Pharmacology Studies, you will be embedded in the heart of early clinical development focused in clinical pharmacology. You will not be watching from the sidelines - you will be designing and providing clinical oversight for the clinical studies that move promising compounds from concept into patients' hands.

From drafting protocols and informed consent documents, reviewing clinical data for emerging trends, and authoring and/or reviewing clinical study reports, your fingerprints will be on every critical milestone of a clinical study. That is not a small thing - that is science with stakes.

What Your Day-to-day Actually Looks Like

You will collaborate with some of the brightest minds in the field - cross-functional teams consisting of internal and external stakeholders - to bring rigour and clarity to complex, fast-moving, early development clinical pharmacology studies.

Concretely, you'll be

• 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

What You Will Gain Beyond The Job Title

• Depth of scientific impact - You will work across the lifecycle of early development clinical pharmacology studies (from phase 1 through phase 2a). The breadth will accelerate your development in ways that siloed roles simply cannot match.
• A global stage - Partnering internationally with KOLs, regulatory bodies, and cross-functional teams means your work and your network has no borders
• A clear growth trajectory - Reporting to the Executive Director of Clinical Science, you will have both the support of experienced leadership and the autonomy to build your capabilities
• The frontier of clinical pharmacology in early drug development - You will be working in the dynamic early development therapeutic areas of immunology, cardiovascular, haematology, and oncology
• A culture that backs you - BMS is a place where collaboration is encouraged daily. It is how “things get done.” You will be part of a team that challenges each other and champions each other in equal measure.

You will thrive here if you…

• Hold a degree in Life Sciences (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

Have intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (eg, patient profiles/narratives, report generating tools, etc)

Why BMS? Why now?

BMS has a bold ambition to transform patients' lives through science. In this department it means being on the forefront of early drug development clinical pharmacology studies in support of tackling diseases that rob people of their quality of life.

BMS is at a pivotal moment in its early drug development clinical pharmacology pipeline, and the clinical scientists we bring on board today help define what is possible tomorrow.

A truly global role with approximately 10 – 20% domestic and international travel required

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https //careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Bristol Myers Squibb is Disability Confident – Employer

A UK Government scheme

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/

R1604160 Senior Manager, Early Clinical Development, Clinical Pharmacology Studies