Associate Director Global Clinical Scientist Full-time

Associate Director Global Clinical Scientist

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.

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.

Position Summary

The Director, Global Clinical Scientist is a member of the Late Clinical Development Function which provides the scientific expertise necessary to design and deliver clinical studies and programs with high quality and urgency.

• Individual contributor role providing support across program(s)

• Serves a key role in the implementation of the Global Clinical Development Strategy for the assigned book of work within an asset and/or indication(s). This includes serving as a subject matter expert and having the capability to represent the CS group in cross-functional initiatives

• Ensures consistency across studies within an asset and/or indication

• Provides support for clinical studies within the assigned asset or indication

• Provides input to strategic discussions and development of clinical development plans (CDPs)

Key Responsibilities

• Serve as a subject matter expert for the development, conduct and regulatory submission of clinical studies including but not limited to

• Protocol development

• Clinical data review

• Data interpretation; review and validation of CSRs

• Regulatory requirements and documents (e.g., IB, submissions, etc)

• Site/KOL engagement strategies and implementation

• Harmonization of standards across programs and/or indications (e.g. data standards, programming specifications, statistical analysis plans)

• Ensure lessons learned are communicated across teams and ensure alignment so that unnecessary amendments are avoided and to align with asset/TA-level protocol elements

• May serve as Trial Lead for complex clinical studies

• May present data/information to internal and external stakeholders including investigators and study staff

• Independently, proactively, and consistently develop, enact, and share best practices

• Clinical oversight of study data, specifically, leverages best practices to guide the CS team(s) in:

• understanding interdependencies of CRFs

• data conventions/ rules

• data review tools and visualizations; collaboration with DM and Programming

• Serve as peer coach or mentor

• Actively participate and demonstrate clinical leadership in study team meetings and other cross-functional meetings as warranted

• Plan execution of deliverables and anticipate future work/identification of issues, and remediation activities

• Partner with CCOE Clinical Capabilities Team to represent CS function in cross functional activities, support or lead process improvement and departmental training activities

Qualifications & Experience

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)

• 10+ years of experience in Clinical R&D roles/responsibilities, including functioning in a matrix environment

• Recognized as a Therapeutic Area and/or Functional expert

Key Competency Requirements:

• Advanced knowledge of GCP/ICH, overall drug development process from discovery to registration, study design, statistics, clinical operations, regulatory environment

• Advanced verbal, written, communication and interpersonal skills.

• Must be able to effectively collaborate across all functions and all job levels

• Ability to assimilate technical information quickly

• Demonstrated ability to influence within study team, TA, department, functions

• Leadership presence and strong presentations skills

• Proactive / Drive for results

• Proficiency in leading teams and activities

• Advanced knowledge and skills to support scientific data review, trend identification, data interpretation, and reporting

• Advanced knowledge of the therapeutic area

• Advanced critical thinking, problem solving, decision making skills

• Commitment to Quality

• Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)

• Advanced planning/project management skills (ability to develop short to long-range plans that are realistic and effective in meeting goals)

• Embodies collaborative spirit, enterprise mindset, ability to implement action

• Travel: Domestic and international travel may be required