Senior Clinical Scientist (Associate Director), Early Clinical Development - Hematology/Oncology & Cell Therapy (R1556335-en-us-1)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Early Clinical Development (ECD-HOCT) team at BMS is responsible for hematology, oncology and cell therapy pipeline assets and sits at the interface between discovery and translational science and clinical drug development. Composed of physician-scientists and clinical-scientists, this group oversees the early development of both internal and partnered assets covering all platforms of therapies, including small molecules, traditional and complex biologics and next gen cell therapies. Therapeutic areas span the full range of hematologic and solid tumor indications. The ECD-HOCT team interacts hand-in-glove with discovery and translational scientists, project leadership, late development and commercial colleagues to optimize biomarker, patient enrichment, dosing and combination strategies to enable faster and more effective drug development informed by core scientific principals and data.
Functional Area Description
The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
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 physician(s).
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.
Evaluate innovative trial designs in collaboration with the study physician.
Manage protocol 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 site-facing activities such as training and support for clinical questions.
Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review.
Identify clinical data trends; 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
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar 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.
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.
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 ability 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.
Domestic and international travel may be required (approximately 10-20%)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.