Director, Early Clinical Development (MD), Autoimmune Cell Therapy

Bristol Myers Squibb; Princeton (NJ); On-site; USD 275,000 - 375,000; Full time

Job summary

Join a forward-thinking company that is redefining the landscape of healthcare through innovative therapies. This role as Director of Early Clinical Development offers a unique opportunity to lead clinical trials in hematology and cell therapy, contributing to groundbreaking advancements that transform patient lives. Collaborate with diverse, high-achieving teams to navigate the complexities of clinical research, ensuring that each trial meets the highest standards of medical oversight and scientific integrity. If you are passionate about making a difference in the medical field, this position will empower you to drive meaningful change and shape the future of healthcare.

Benefits

Competitive benefits

Incentive cash and stock opportunities

Workplace accommodations for disabilities

Qualifications

• 5+ years in clinical research with leadership experience in pharmaceutical industry.
• Advanced degree in relevant field required, MD/PhD preferred.

Responsibilities

• Oversee multiple clinical trials and provide medical accountability.
• Design and develop clinical studies in partnership with leadership.

Skills

Clinical trial leadership

Medical monitoring

Data analysis and interpretation

Communication skills

Leadership skills

Education

MD or MD/PhD

Subspecialty fellowship in rheumatology or hematology

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 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.
Director, Early Clinical Development (MD) - Hematology & Cell Therapy with Focus in Cellular Therapy for Autoimmune Indications
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 (including diverse indications spanning oncology, hematology, rheumatology, immunology, neurology, etc.) pipeline assets and sits at the interface between discovery and translational science and clinical drug development.
Position Summary / Objective

1. Serves as a primary source of medical accountability and oversight for multiple clinical trials
2. Manages Phase I/II studies, with demonstrated decision making capabilities
3. Provides medical and scientific expertise to cross-functional BMS colleagues
4. Maintains matrix management responsibilities across internal and external networks

Position Responsibilities
Medical Monitoring

1. Independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept
2. Articulating clinical development strategy
3. Analyzing, interpreting, and acting on Clinical Trial data to support development
4. Serving as principal functional author for Regulatory submission, study reports, and publications
5. Provides oversight and medical accountability for multiple trials across early development clinical lifecycle
6. Manages site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
7. Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
8. Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
9. Collaborates with CS and provides input into protocols, contributing medical strategic oversight in protocol development
10. Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
11. Acts as a focal point for defining and establishing relationships with key global Phase I Centers
12. Works on multiple trials across early development clinical lifecycle

Clinical Development Expertise & Strategy

1. Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team
2. Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection
3. Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
4. Partners with CS to support executional delivery of studies
5. Maintains a strong medical/scientific reputation within the disease area
6. Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature
7. Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development
8. Provides ongoing medical education in partnership with CS
9. Ad-Hoc involvement in various departmental initiatives
10. Presents and/or articulates clinical strategy to senior leadership

Health Authority Interactions

1. Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician
2. Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents

External Partnerships, Alliances, and Publications

1. Sits on team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies
2. Represents department in business development due diligence and partner alliance management
3. Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers
4. Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences)

Degree Requirements

1. Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area
2. Subspecialty fellowship training in rheumatology or hematology area preferred

Experience Requirements

1. 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting
2. Clinical trial leadership experience within pharmaceutical industry preferred
3. Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting preferred

Key Competency Requirements

1. Ability to communicate and present information clearly in scientific and clinical settings
2. Expertise in the scientific method to test hypotheses
3. Knowledge of drug development process
4. Strong leadership skills with proven ability to lead and work effectively in a team environment

The starting compensation for this job is a range from $275,630-374,100, plus incentive cash and stock opportunities (based on eligibility).
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

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 [e-mail].

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.