Regeneron logo

Director, Clinical Scientist, Hematology

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

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: bachelorโ€™s degree; advanced degree or equivalent in life science/healthcare (PhD/MD/PharmD/MSc) preferred
  • โ‰ฅ 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

  • Bachelorโ€™s degree required; advanced degree preferred (PhD/MD/PharmD/MSc)

Additional Requirements

  • None beyond the role scope; travel/physical requirements not specified as essential
Apply now
Share this job