Overview
Working with Us. Challenging. 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. 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.
The 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.
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 internal and external forums as the consulted authority for the disease area
* 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 Statisticians
Qualifications & 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 experience
Experience 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 Attributes including synthesizing data to produce a clinical strategy, ensuring a viable registrational strategy, leading hiring efforts, and driving enterprise level strategy for asset(s) and indication(s).
* 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)
* 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
Key Competency Requirements
* CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)
* External focus to understand trends in disease area treatment paradigms and the ability to build relationships with external partners
* Ability to coordinate with Early Development and ensure seamless transition into late-stage development (Phase II-III)
* Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs
Travel Required
* Domestic and International travel may be required.
Compensation & Benefits
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/.
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, and other protections.
Work-life benefits include:
* Paid Time Off: US Exempt Employees have flexible time off; 11 paid national holidays. Other locations have applicable policies.
All global employees eligible to participate in the Global Shutdown between Christmas and New Year\'s Day. Eligibility details vary by region. See benefits for more information.
Uniquely Interesting Work, Life-changing Careers: With Transforming patients\' lives through science as our vision, every BMS employee plays an integral role in work that goes beyond ordinary and is guided by our values of passion, innovation, urgency, accountability, inclusion and integrity.
On-site Protocol and Compliance: BMS occupancy models and expectations are described for roles, including site-essential, site-by-design, field-based and remote-by-design. For inquiries about accommodations, contact adastaffingsupport@bms.com. See careers.bms.com/eeo-accessibility for Equal Employment Opportunity information.
Candidate Rights: BMS will consider qualified applicants with arrest and conviction records as required by law. For residents of Los Angeles County or California, see additional information here: https://careers.bms.com/california-residents/.
Data Protection: We will never request payments or sensitive information during the application process. Learn more at https://careers.bms.com/fraud-protection. All data processed will be managed per applicable data privacy policies. For missing information, contact TAEnablement@bms.com with Job Title and Requisition number.
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