**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 rich in diversity. 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: careers.bms.com/working-with-us . **Functional Area Description** The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. + Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision. + Provides scientific and clinical leadership to clinical scientists on study team (matrix leadership). + May support clinical development planning in collaboration with Early Clinical Development p hysician (s) . **Position Responsibilities** + Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members. + Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable. + Evaluat e innovative trial designs in collaboration with the study physician . + Manage p rotocol and ICF development process (e.g., documents and amendments) with minimal guidance ; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to governance committee and early clinical development team meetings as required . + Serve as primary contact for s ite-facing activities such as training and support for clinical questions. + Conduct and oversee a ctivities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review . + Identif y c linical data trend s; provide trends and escalate questions to study physician . + Develop clinical narrative plan and review clinical narratives. + Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc. + Review /develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., safety review ) activities. + Author /review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses). + Collaborate and serve as primary liaison between external partners for scientific advice. + Author/review abstracts, presentations, and manuscripts for external publications **Reporting Relationship** + Report to Director, Clinical Scientists, Early Development **Degree Requirements** + Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred) . **Experience Requirements** + 5+ years of experience in clinical science, clinical research, or equivalent. + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. + Proficient knowledge and skills to support program specific data review, trend identification, data interpretation + Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees . **Key Competency Requirements** + Excellent verbal, written, communication and interpersonal skills . + Must be able to effectively communicate and collaborate across functions and job levels . + Ability to assimilate technical information quickly . + Routinely takes initiative . + Detail-oriented . + Strong sense of teamwork; ability to lead matrix team activities . + Proficient in Medical Terminology and medical writing skills . + Proficient knowledge of the disease area(s), KOLs, indication (s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile) . + Proficient critical thinking, problem solving, decision making skills . + Understanding of functional and cross-functional relationships . + Commitment to Quality . + Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an a bility to meet day-to-day challenges with confidence and professionalism . + Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals) . + Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools . **Travel Required** + Domestic and international travel may be required ( approximately 10-25 %) 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 an inclusive culture, promoting diversity 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 a diverse 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. 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 . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1587590 **Updated:** 2024-12-27 06:14:33.559 UTC **Location:** Princeton-NJ Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.