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. This is an individual contributor role providing support across program(s) and 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). The role includes serving as a subject matter expert and representing the CS group in cross-functional initiatives, ensuring consistency across studies within an asset and/or indication, and providing input to strategic discussions and development of clinical development plans (CDPs).

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

• 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

Additional Requirements

• Travel domestically and internationally may be required.