Executive Director, Global Trial Management, TA Head for Hematology/Oncology Early Development

Company: Disability Solutions
Location: Princeton
Posted on: September 1, 2024

Job Description:

Working with UsChallenging. Meaningful. Life-changing. Those aren't 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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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: careers.bms.com/working-with-us .Job Title: Executive Director, Global Trial Management, TA Head for Hematology/Oncology Early Development Functional Area Description: The general manager for all strategic and executional activities within a specified therapeutic area in either research and early development, full drug development or late phase development.Position Summary: The Therapeutic Head of Clinical Operations is a senior role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Vice President of Global Trial Management (GTM) within Global Development Operations (GDO) and is a key member of GTM Leadership. Position Responsibilities:

• Providing strategic and clinical operational leadership across a therapeutic area, for example: immunology; neuroscience; cardiovascular; solid tumors; cellular therapy or hematology.
• Assuring the implementation of that therapeutic area strategy through one of the following phases - supporting early development bringing the assets through proof of concept; supporting full development to secure regulatory filings; supporting late development focused on non-registrational drug development programs - Phase IV studies, patient access programs and investigator initiated studies.
• Driving the performance, operational quality, innovative development strategies/trial designs, and the timely contributions to assure successful implementation, execution, and delivery across the entire therapeutic area.
• Partnering with the key areas of the R&D business, he/she provides oversight and leadership that supports the design and execution of development programs that enable proof of concept, regulatory approvals or successful market access. Serving as an escalation point, when development teams are not able to resolve conflicts and is a core member of cross-functional leadership teams.
• Ensuring the operational execution of all clinical development programs within the therapeutic area; providing operational insight into study designs; ensuring the timely recruitment of BMS-sponsored clinical trials; assuring the collection and cleaning of clinical data; ensuring oversight through to support regulatory filings (as relevant); and developing/maintaining relationships with key clinical trial sites and investigators in the therapeutic area.
• In collaboration with clinical compliance and other functions, support strict adherence to GCP principles, enabling ongoing inspection-readiness and successful implementation of CAPAs.
• Leading a multi-national team of clinical trial professionals, who are experts in the execution of clinical operations, contributing significantly to BMS portfolio of clinical trials. Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowers and holds GDO management to high-quality performance and delivery of the business.
• Representing the Company in key interactions with key external partners as part of any therapeutic area committee or industry group.
• Serving as a leader within Global Development Operations (GDO) and developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management. Ensuring GDO representation as needed in governance or strategic teams or committees (preparatory materials, direct participation, or representative).
• Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.
• Developing and promoting a workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.Degree Requirement: Minimum BS or BA degree, advanced degree preferred Experience Requirements:
  • > 15 yrs. of relevant industry experience
  • Substantial experience of managing senior clinical operations staff in a global setting. In-depth knowledge of the drug development process and overall planning, project management and clinical operations of a clinical development program.
  • Proven significant experience within the assigned therapeutic area.
  • Recognized skill in managing drug development programs, across multiple therapeutic areas, and major geographies.
  • Experience in the design strategy and execution of clinical programs across all phases of development including a demonstrated capability in support of proof of concept, full development and/or across marketed products.
  • Experience in conducting global clinical trial programs across major worldwide markets, including the partnership with CROs, SMOs, AROs and local site networks. Direct experience of leadership of a CRO or from within a CRO strongly preferred Key Competency Requirements: Operational Leadership/Decision making
    • Develops project standards and ensures consistency and efficiency across the program
    • Manages a disciplined approach to accurate documentation of the team's work
    • Consistently makes operational decisions in a timely manner
    • Uses expert judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities
    • Acts decisively to address team challenges
    • Contributes to business strategy from an operational perspectiveCommunication
      • Effective oral and written communication skills to influence inform and guide a large-scale global operational team.
      • Provides vision to build partnerships across functional area leadership
      • Consistently demonstrates positive attitude about the team's ability to deal with challenges
      • Drives issues to resolution; communicates to ensure that issues have been worked through to completion
      • Applies change management principles to support communication and implementation of integrated change
      • Demonstrates diplomacy when interfacing with other functional areas, clinical research organizations (CROs) and other outside vendors.Stakeholder Management
        • Strong leadership competencies and influencing skills with senior leaders and cross-functional leaders.
        • Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.
        • Frequently communicates program status to different levels of stakeholders 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. Uniquely Interesting Work, Life-changing CareersWith 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 an inclusive culture, promoting diversity 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 a diverse 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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