Director, Early Clinical Development - San Diego, United States - Bristol-Myers Squibb

Bristol-Myers Squibb

Verified Company

San Diego, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

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.

The Director will be the clinical lead to progress early clinical assets from first-in-human through proof-of-concept and will prepare the clinical development plan, design clinical trials and lead the clinical development team.

Experience in early clinical development of neurodegenerative and/or neuropsychiatric indications is a requirement. Demonstrated expertise in basic research related to neurodegeneration and/or neuropsychiatry is a plus.

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 crossfunctional 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 ProofofConcept 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 safetyrelated 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 safetyrelated 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 firstinhuman 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, nonsignificant deviations etc.)
Maintains a strong medical/scientific reputation within the disease area; has indepth 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 protocolspecific training, supporting the study team, investigators, and others
Ad-Hoc involvement in various departmental initiatives (e.g., committees, subteams 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 s