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Director, Clinical Scientist, Hematology

Regeneron
Full-time
Remote friendly (Warren, NJ)
United States
Clinical Research and Development

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Role Summary

Director, Clinical Scientist, Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The role involves leading in a matrix environment as part of a cross-functional team, contributing to early and late phase development, and managing a team of clinical scientists.

Responsibilities

  • May function as lead Clinical Scientist for a program, and/or as delegate of Therapeutic Area Lead Clinical Scientist; member of the Clinical Study Team and Global Clinical SubTeam
  • Line Manager for CS team; serves as key functional advisor for the CS group; ensures alignment of processes/procedures across assigned assets/programs; guides assigned program teams/direct reports
  • Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments
  • Applies advanced scientific expertise to propose, design, and execute clinical research and development studies for early and late stage assets; develops strategy proposals grounded in supporting literature
  • Authors/reviews trial documents (medical monitoring plans, SAPs, informed consents, clinical components of Clinical Study Reports); supports development of regulatory documents; performs quality review/approval; resolves cross-functional comments; leads planning for external/stakeholder meetings
  • Mentors direct reports in clinical/medical data review, including safety monitoring and patient safety procedures
  • Applies analytical knowledge to understand how objectives/design impact data analysis; identifies risks and designs mitigation strategies
  • Ensures first-line medical/clinical data review techniques across studies/programs; leads drafting/updating/review of clinical data review and medical monitoring plans; ensures execution where appropriate

Qualifications

  • Required: bachelor’s degree; advanced degree or equivalent in life science/healthcare (PhD/MD/PharmD/MSc) preferred
  • ‚â• 10 years of pharmaceutical clinical drug development experience
  • Experience with lymphoma/hematology oncology
  • Minimum of 4 years of direct and/or indirect management experience
  • Understanding of therapeutic disease areas and drug candidates, disease biology, clinical manifestations, therapeutic standard practice, mechanism of action and drug landscape
  • Other levels considered depending on experience

Skills

  • Ability to build and mentor teams; strong matrix leadership
  • Professional diplomacy and influence across functions
  • Initiative, creativity, and innovation; ability to drive operational changes
  • Strong management, interpersonal and problem-solving skills

Education

  • Bachelor’s degree required; advanced degree preferred (PhD/MD/PharmD/MSc)

Additional Requirements

  • None beyond the role scope; travel/physical requirements not specified as essential
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