Senior Manager, Early Clinical Development, Clinical Pharmacology Studies

Job description

**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: [](https://careers.bms.com/working-with-us). 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*** #LI-Hybrid *If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.* **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. **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 [adastaffingsupport@bms.com](mailto:adastaffingsupport@bms.com). Visit [](https://careers.bms.com/eeo-accessibility)[eeo](https://careers.bms.com/eeo-accessibility)[-accessibility](https://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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. **Data Protection** We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at [](http://careers.bms.com/fraud-protection). Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [TAEnablement@bms.com](mailto:TAEnablement@bms.com). Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1604160 : Senior Manager, Early Clinical Development, Clinical Pharmacology Studies