Clinical Development Program Lead, Neuropsychiatry
Clinical Development Program Lead, Neuropsychiatry
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams. 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: Summary
The ClinicalDevelopment Program Leadersits within Clinical Development which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy design execution and interpretation of clinical trials.
The Clinical Development Program Leader will set the clinical development strategy for assets or indications
The Clinical Development Program Leader will directly supervise the work of multiple Clinical Development Leads who will in turn supervise individual Clinical Trial Physicians unless otherwise indicated
This role will include above disease / indication strategy work (i.e. supervising Broad Clinical Development teams across several Development teams as well as Disease / Indication Strategy teams etc.)
The role will be foundational in working with teams in R & ED and GDD to support GT4/5 and POC transitions providing insights into biology translational elements as well as overall benefit risk assessments
The role will supervise the development of differentiated and strategic Clinical Development Physicians (CDPs) for multiple transition assets and support a broad program of work from phase I expansion through to registrational execution
The role includes support of across portfolio activities in line with Clinical Excellence including e.g. Protocol Review Committee support of Business Development activities and Quality and Compliance leadership
The role will report directly to the Head of Clinical Development and will deputize as required and will be a core member of the Therapeutic Area clinical development executive leadership team
Key Responsibilities
Strategy and Execution
Create and communicate a vision for designing conducting and executing innovative clinical development plans
This leader will supervise the development monitoring analysis and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings
Will contribute to overall strategy for specific disease / indications while ensuring a franchise overall portfolio view
Provide strategic insights into the clinical development plans
Lead search and evaluation activities on business development due diligence efforts and advice to our strategic transactions group
Key Member of Therapeutic Area Clinical Development Leadership Team and chairing forum as required
Chair departmental Staff Meetings and represent governance meetings on an ad hoc basis
Will build a franchise reputation that attracts innovators to bring their ideas to BMS
Drug Development Experience
Will create a Clinical Development strategy to develop programs beyond commercialization and launch and into lifecycle management
Leadership and Matrix Management
Lead and develop a group of Clinical Development professionals (team of up to 50 individuals both direct and indirect) whose therapeutic area focus is in a specific disease area / indication and will ensure scientific and technical excellence of clinical development programs and deliverables
This individual will recruit develop and retain strong talent
Mentoring of talent/staff
Will establish an effective and ethical culture that encourages teamwork peer review promotes cooperation and provides a supportive culture
Will be responsible for developing a culture that values diversity of thought supports coaching fosters accountability and integrity and supports process excellence and continuous improvement
Will be responsible for oversight of team budget and headcount
Stakeholder Engagement and Communication
Will work closely with colleagues in BMS Research Development Regulatory Medical Commercial and other key functional areas on a global basis; additionally should have an external focus and build relationships with thought leaders physicians and patient advocacy groups outside of BMS. Be recognized internally and externally as an expert in the field
Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof of concept trials and will assure a seamless transition into late stage development (Phase IIIII trials.)
Governance Participation and Signature Authority
Governance participation ad hoc as designated
PRC Chair ad hoc as needed
Signature Authority for: CSRs Health Authority Briefings DMC Charters Unblinding Requests Health Authority Documents for Filings and other clinical accountable documents delegated as needed
Qualifications & Experience
MD (PhD or other high level degree optional)
Experience Requirements:
The ideal candidate will be a clinical development leader; with greater than 10 years of extensive clinical trial drug development and regulatory experience in addition to a strong scientific background
Management experience will be important since this individual will manage a group of professionals including MDs or PhDs or PharmDs with clinical research experience.
The successful candidate will understand earlystage drug development extensive experience designing and conducting Phase I II and Phase III clinical trials and should have demonstrable success filing regulatory dossiers and prosecuting them through approval
Global experiences is a plus since this position has responsibility for strategy and clinical research in Neuropsychiatry in multiple geographies
Experience interacting with business development and licensing particularly helping to evaluate the technical and franchise aspects for potential inlicensing opportunities that shape the Neuropsychiatry clinical development strategy
Key Competency Requirements:
Proven track record in managing complex clinical programs leading to regulatory submissions
Deep understanding of Biology targets and translational science
Extensive experience of work with health authorities at all levels
Proven differentiated ability to support and manage across the totality of the spectrum including development of registrational and nonregistrational trials
Proven ability to execute the BMS R&D People Strategy and lead and develop a matrix team
The candidate also must be a highly effective leader capable of working with Commercial Medical and all research functions of the company from Research through Regulatory
The candidate must be comfortable with crossfunctional drug and product development teams and managing in a matrix environment
In addition the candidate must be skilled at interacting externally and at speaking engagements
Must be skilled at attracting developing and retaining skilled professionals
Travel Required
Domestic and International travel may be required.
#lihybrid
If you come across a role that intrigues you but doesnt 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 Lifechanging 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 a supportive culture promoting global participation 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100% of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Employment Type
Full-Time
