Director, Early Clinical Development (MD) - Hematology & Cell Therapy

Bristol Myers Squibb • Princeton, NJ

43d • $275,630 - $374,075

About The Position

The Director, Early Clinical Development role will focus on the emerging and rapidly expanding area of cellular therapy for autoimmune indications. Physician-scientists and clinical-scientists within this group oversee the early development of both internal and partnered assets covering all cellular therapy platforms for autoimmune conditions. Therapeutic areas span the full range of autoimmune disorders, including hematology, rheumatology, and neurology. 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, and dosing strategies to enable faster and more effective drug development informed by core scientific principles and data. The Early Clinical Development - HOCT function is part of a global organization dedicated to the effective design and execution of early drug development. Early Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.

Requirements

• Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent)
• 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
• Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry preferred OR
• Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting preferred including demonstrable achievement in experimental design, interpretation and exposition
• Ability to communicate and present information clearly in scientific and clinical settings
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Knowledge of drug development process
• Knowledge of the components needed to execute an effective clinical plan and protocols
• Strong leadership skills with proven ability to lead and work effectively in a team environment

Nice To Haves

• Subspecialty fellowship training in rheumatology or hematology area preferred
• Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry preferred OR
• Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting preferred including demonstrable achievement in experimental design, interpretation and exposition

Responsibilities

• 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
• 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, and
• 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 (CS) for medical questions and education (including safety management guidelines)
• Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees 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 CS 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.
• 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, 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 CS 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 CS 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 and/or articulates clinical strategy to senior leadership and to support progression of portfolio
• Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists
• Sits on team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies
• Represents department in business development due diligence and partner alliance management with oversight
• Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers
• Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)

Benefits

• 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.
• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees