Executive Director, Clinical Development Program Lead (Neuropsychiatry)

Bristol Myers Squibb•Needham, MA

4d•Onsite

About The Position

The Clinical Development Program Leader sits within Clinical Development, a global organization dedicated to the effective design and execution of drug development. This role 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 and will directly supervise the work of multiple Clinical Development Leads who will in turn supervise individual Clinical Trial Physicians. This role will include above disease/indication strategy work, supervising broad Clinical Development teams across several Development teams, as well as Disease/Indication Strategy teams. 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, and 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 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)
Greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong scientific background.
Management experience is important since this individual will manage a group of professionals including MDs or PhDs or PharmDs with clinical research experience.
Understand early-stage drug development.
Extensive experience designing and conducting Phase I, II and Phase III clinical trials.
Demonstrable success filing regulatory dossiers and prosecuting them through approval.
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.
Highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory.
Comfortable with cross-functional drug and product development teams and managing in a matrix environment.
Skilled at interacting externally, and at speaking engagements.
Skilled at attracting, developing, and retaining skilled professionals.

Nice To Haves

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.

Responsibilities

Create and communicate a vision for designing, conducting and executing innovative clinical development plans.
Supervise the development, monitoring, analysis and interpretation of clinical trials.
Supervise and have accountability for the clinical components of regulatory filings.
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 the strategic transactions group.
Chair departmental Staff Meetings and represent governance meetings on an ad hoc basis.
Build a franchise reputation that attracts innovators to bring their ideas to BMS Drug Development.
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.
Recruit, develop and retain strong talent.
Mentor talent/staff.
Establish an effective and ethical culture that encourages teamwork, peer review, promotes cooperation and provides a supportive culture.
Develop a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and supports process excellence and continuous improvement.
Oversee team budget and headcount.
Work closely with colleagues in BMS Research, Development, Regulatory, Medical, Commercial and other key functional areas on a global basis.
Build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS.
Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof of concept trials and 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

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
Unlimited paid sick time (based on eligibility).
Up to 2 paid volunteer days per year.
Summer hours flexibility (for US office-based employees, eligibility may vary).
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.