Senior Clinical Scientist II

Role Summary

The Sr Clinical Scientist II is a member of the Clinical Science function which provides the scientific expertise necessary to design and deliver clinical studies and programs with high quality and urgency.

Responsibilities

• 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)
• 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

• 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

Skills

• 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

Education

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

Additional Requirements

• Travel: Domestic and international travel may be required