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Director Early Clinical Development, Neuroscience

Company: Bristol Myers Squibb
Location: Cambridge
Posted on: November 25, 2022

Job Description:

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.

Director, Early Clinical Development

Functional Area Description
The Early Clinical Development function is part of a global scientific organization dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for later development.

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 and/or articulates clinical strategy to senior leadership and to support progression of portfolio

Health Authority Interactions
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
External Partnerships, Alliances, and Publications
Sits in 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.)

Degree 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)
Subspecialty fellowship training in applicable therapeutic area preferred

5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable

Key Competency Requirements
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

Travel Required
Domestic and International travel may be required

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. - Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. - This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol Myers Squibb, Cambridge , Director Early Clinical Development, Neuroscience, Executive , Cambridge, Massachusetts

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