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Position Summary 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
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 II-III 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 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
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 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
Travel Required
- Domestic and International travel may be required.
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.
Compensation Overview: $340,870 - $413,051
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.
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.
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 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.
On-site Protocol BMS has an 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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility 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.
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: https://careers.bms.com/california-residents/
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