Director, Early Clinical Development - New York, United States - Bristol-Myers Squibb

Description

Director, Early Clinical Development (MD) - Neuroscience page is loaded

Director, Early Clinical Development (MD) - Neuroscience

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locations

Cambridge Crossing - MA - US

Princeton - NJ - US

San Diego - CA - US

Summit West - NJ - US

time type

Full time

posted on

Posted 16 Days Ago

job requisition id

R

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.

Read more:
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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

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

Experience Requirements
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

The starting compensation for this job is a range from $270,000 to $305,000 plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

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 our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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.
#LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.

You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary.

Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.

The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.

For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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

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to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.

As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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.

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