Executive Director, Global Clinical Development (Neuroscience)

Bristol Myers Squibb•Needham, MA

7d•$340,870 - $413,051•Onsite

About The Position

The Clinical Development Program Leader, within the global Clinical Development organization, is responsible for the effective design and execution of drug development. This role drives clinical development strategy, design, execution, and interpretation of clinical trials. The individual will set the clinical development strategy for assets or indications, directly supervise Clinical Development Leads, and oversee above disease/indication strategy work. This role is foundational in supporting GT4/5 and POC transitions by providing insights into biology, translational elements, and benefit-risk assessments. It involves supervising the development of Clinical Development Physicians (CDPs) for transition assets and supporting a broad program from phase I expansion through registrational execution. The role also includes support of across-portfolio activities such as Protocol Review Committee, Business Development activities, and Quality and Compliance leadership. The position reports directly to the Head of Clinical Development and serves as 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.
Strong scientific background.
Management experience (managing a group of professionals including MDs, PhDs, or PharmDs with clinical research experience).
Understanding of early-stage drug development.
Extensive experience designing and conducting Phase I, II, and 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 working 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 experience 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 the overall strategy for specific disease/indications while ensuring a franchise overall portfolio view.
Provide strategic insights into clinical development plans.
Lead search and evaluation activities on business development due diligence efforts and advise 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, direct and indirect) with a therapeutic area focus in a specific disease area/indication.
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 external relationships with thought leaders, physicians, and patient advocacy groups.
Partner and interact with colleagues from Research and Early Development to ensure a seamless transition into late-stage development (Phase II-III trials).
Participate in governance ad hoc as designated (e.g., PRC Chair).
Provide signature authority for CSRs, Health Authority Briefings, DMC Charters, Unblinding Requests, Health Authority Documents for Filings, and other clinical accountable documents.

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 (based on eligibility).
Summer hours flexibility (based on eligibility and location).
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day (for all global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year).