Director, Early Clinical Development
vor 3 Wochen
**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.
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**
**Position Summary / Objective**
- Serves as a primary source of medical accountability and oversight for multiple clinical trials
- Manages Phase I/II studies, with demonstrated decision making capabilities
- Provides medical and scientific expertise to cross-functional BMS colleagues
- Maintains matrix management responsibilities across internal and external networks
**Position Responsibilities**
**Medical Monitoring**
- Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by
- Articulating clinical development strategy
- Analyzing, interpreting, and acting on clinical trial data to support development
- Serving as principal functional author for Regulatory submission, study reports, and publications
- Provides oversight and medical accountability for multiple trials across early development clinical lifecycle
- Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
- Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives
- Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
- Collaborates with Clinical Scientists and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
- Acts as a focal point for defining and establishing relationships with key global Phase I Centers
- Works on multiple trials across early development clinical lifecycle
**Clinical Development Expertise & Strategy**
- Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies
- Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
- Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
- Partners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
- Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder
- Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature
- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
- Provides ongoing medical education in partnership with Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
- Ad-Hoc involvement in various departmental initiatives (e.g., committees, sub-teams etc.)
- Presents an
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