Executive Director, Clinical Development Program Lead (Neuropsychiatry)

Bristol Myers Squibb•San Diego, CA

32d

About The Position

The Clinical Development Program Leader sits 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

Requirements

MD (PhD or other high level degree optional)
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 early-stage 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 oncology in multiple geographies
Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy
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 non-registrational 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 cross-functional 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

Responsibilities

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
Will create a Clinical Development strategy to develop programs beyond commercialization and launch and into lifecycle 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
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 II-III trials.)
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

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.

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