Clinical Development Lead, Oncology

Company: Disability Solutions
Location: Cambridge
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 .Position SummaryThe Clinical Development Lead 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.

• CDLs are matrix leaders and managers who lead, develop, motivate and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People Strategy
• Serves as the clinical point of accountability for the Development Team and is responsible for the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s)
• Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals
• Serves as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs)Key Responsibilities
  • Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication
  • Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
  • May serve as CTP as necessary
  • Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles
  • Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
  • Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
  • Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
  • Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
  • Serves as the (co-)leader of the cross-functional Clinical Development Team
  • Provides clinical leadership and disease area expertise into integrated disease area strategies
  • Partners closely with KOLs in specific indications
  • Serves as Primary Clinical Representative in Regulatory interactions
  • Evaluates strategic options against a given Target Product Profile (TPP)
  • Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
  • Sets executional priorities and partners with CTP and CS to support executional delivery of studies
  • Accountable for top line data with support of CTP, CS, and StatisticiansQualifications & Experience
    • MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
    • At least 10 years of relevant experienceExperience Requirements:CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes:
      • Able to synthesize internal and external data to produce a clinical strategy
      • Able to ensure that the clinical program will result in a viable registrational strategy
      • Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts
      • Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio
      • CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent
      • Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues)Key Competency Requirements:
        • CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)
        • External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS
        • Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials)
        • Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables 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. 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.

Keywords: Disability Solutions, Cambridge , Clinical Development Lead, Oncology, Healthcare , Cambridge, Massachusetts