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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

The Director Clinical Sciences, Hematology leads the development, evaluation, planning and execution of clinical studies, ensuring scientific integrity and interpretation of study data within a clinical development program. This role oversees a team of clinical scientists, works in a matrix cross-functional environment, and collaborates with Medical Directors to design and deliver clinical studies and programs.

Responsibilities

  • May function as lead Clinical Scientist for a program or as a delegate of the Therapeutic Area Lead Clinical Scientist; member of the Clinical Study Team and Global Clinical SubTeam.
  • Line management for the CS team; ensures alignment of CS processes across assets/programs in line with TA expectations; guides assigned program teams/direct reports.
  • Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; represents the 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 and/or reviews trial documents (medical monitoring plans, SAPs, informed consents, clinical components of CSRs) and independently supports development of regulatory documents; performs quality review/approval; adjudicates cross-functional comments; leads planning and information for external/stakeholder meetings (IM, Governance, IDMCs, Regulatory Authorities).
  • Mentors direct reports in clinical/medical data review, including safety monitoring and patient safety procedures.
  • Applies analytical knowledge to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies; identifies areas of potential data review inconsistency.
  • Ensures consistent first-line medical/clinical data review techniques across studies/programs; leads drafting/updating/review of clinical data review plans and medical monitoring plans; ensures execution where appropriate.

Qualifications

  • Bachelor’s degree required; advanced degree or equivalent in life science/healthcare preferred (PhD/MD/PharmD/MSc).
  • β‰₯ 10 years of pharmaceutical clinical drug development experience.
  • Experience in lymphoma/hematology oncology; minimum of 4 years of direct and/or indirect management experience.
  • Strong understanding of therapeutic disease areas, drug candidates, disease biology, clinical manifestations, and drug landscape; knowledge of mechanism of action.
  • Other levels considered depending on experience.

Skills

  • Ability to lead activities within a matrix environment; professional diplomacy; ability to influence across teams and functions.
  • Strong initiative, creativity, and innovation; ability to identify operational improvements.
  • Strong direct-line and cross-functional management, interpersonal and problem-solving skills.

Education

  • PhD, MD, PharmD, MSc or equivalent advanced degree strongly preferred; life sciences/healthcare focus.

Additional Requirements

  • None beyond the above. Travel or physical demands not specified as essential to the role.