Lead Clinical Scientist, Multi-Trial Programs

Bristol Myers Squibb; Warszawa; On-site; PLN 392,090 - 475,118; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland is seeking a Clinical Trial Lead to oversee the planning, execution and leadership of assigned trials across development stages. You will guide cross-functional teams, ensure protocol adherence, and drive data quality and strategic trial decisions.

The role requires mentoring clinical scientists, coordinating with protocol managers, and supporting study design with data interpretation and safety considerations.

Qualifications

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
• 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
• 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 team activities
• Proficient in Medical Terminology and medical writing skills
• Proficient knowledge of disease areas, KOLs, indications, compounds under study (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
• Proficient planning/project management skills
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools

Responsibilities

• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
• Plan and lead the implementation of all study startup/conduct/close-out activities as applicable
• Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
• Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross-functional comments and ensuring high clinical quality (collaboration with Medical Writing)
• Site-facing activities such as training and serving as primary contact for clinical questions
• Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
• Clinical data trend identification; provide trends and escalated questions to Medical Monitor
• Develop clinical narrative plan; review clinical narratives
• Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
• Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
• Collaborate and serve as primary liaison between external partners for scientific advice

Job description

Bristol Myers Squibb in Warsaw, Poland is seeking a Clinical Trial Lead to oversee the planning, execution and leadership of assigned trials across development stages. You will guide cross-functional teams, ensure protocol adherence, and drive data quality and strategic trial decisions.

The role requires mentoring clinical scientists, coordinating with protocol managers, and supporting study design with data interpretation and safety considerations.