Clinical Trial Lead, Immunology and Neuroscience
2 weeks ago
**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 rich in diversity. Take your career farther than you thought possible.
**Position Summary**
The Clinical Trial Lead, I&N will be responsible for the day-to-day oversight of the MEG BoW which provides scientific expertise necessary to design and deliver Medical Affairs Sponsored Trials, execute on the ISR book of work, and co-develop Integrated Evidence Plan. The Clinical Trial Lead for assigned asset is responsible for driving the development, tracking, and maintenance of the Integrated Evidence Plan, provide oversight of Investigator Sponsored Research (ISR) Book of Work accountable for ensuring scientific integrity and data quality is maintained during executions of assigned MASTs
**Key Responsibilities**
- Clinical Scientist on assigned MASTs, ensuring quality execution of deliverables for all phases of assigned MASTs (start-up/conduct/closure), through activities such as:
- Protocol design concept sheet, Protocol and ICF development
- Site-facing activities
- CRA training materials
- Data quality activities; ensure consistent, quality data review across trial teams
- Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities
- Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, regulatory responses)
- Develop IEP that reflects asset strategy, market priorities, and medical data generation support in partnership with cross functional teams including (but not limited to) GDD, Translational Development, & HEOR
- Develop Areas of Interest based on key open data questions identified in the IEP with market input in collaboration with WWM
- Identify ISR studies at risk for failing to meet timelines and negotiate mitigation plans with key internal stakeholders and investigators
- Assist in reviews of concepts through RFP process, including providing context for ongoing book of work, area of interest development, and upcoming data read outs
- MEG representative at AIMs for assigned asset and AIMs working team lead
**Qualifications & Experience**
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or other scientific field preferred) with at least 2 years' experience with clinical trial oversight
- Demonstrated proficiency in driving and managing company-sponsored clinical trials and leading teams (e.g., Clinical Scientist team lead)
- Demonstrated track record of leadership in a complex, matrix environment. Experience delivering successful results in a variety of business situations.
- Excellent communication skills and experience with difficult discussions.
- Successful track record of leading through influence and working across complex, global organizational matrices
- Able to analyze, interpret, and present data
- Ability to self-supervise, and act independently to identify/resolve program level issues
- Proficient critical thinking, problem-solving, decision-making skills, oral and written communication skills
- Strong leadership presence
- Commitment to Quality
- Adaptable / Flexible
- Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally
- Promotes a culture of scientific excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality, and effective communication
**#LI-Hybrid**
**Uniquely Interesting Work, Life-changing Careers**
**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 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
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