Senior Medical Director, Clinical Development, Cell Therapy

Location: Tarrytown, New York, or Warren, New Jersey, United States. The role is expected to be performed onsite; travel to relevant congresses and conferences is approximately 10%.

Salary: $333,300–$450,900 annually.

Company

hirify.global is a biotechnology company that develops and commercializes medicines for serious diseases, including cancer, hematologic conditions, and rare diseases.

What you will do

• Provide clinical leadership for assigned sections of Hematology/Oncology cell therapy development programs.
• Manage operational execution of clinical programs and deliverables within approved budgets and timelines.
• Develop clinical sections of Investigators’ Brochures, briefing books, safety updates, and IND/NDA submission documents.
• Lead responses to health authority questions and interactions with regulatory agencies, key opinion leaders, advisory boards, and patient advocacy groups.
• Partner with Clinical Science, Clinical Operations, Safety, Research, Medical Affairs, Marketing, and Health Economics & Outcomes Research.
• Ensure overall compound safety in collaboration with the program Safety Lead.

Requirements

• M.D. or equivalent medical degree, such as D.O. or MBBS.
• Clinical training in a relevant disease area, preferably Hematology or Oncology.
• At least 4 years of clinical research experience in an industry environment across Phases 1 through 4.
• Strong understanding of the global regulatory environment, key regulatory agencies, and approval processes.
• Strong understanding of clinical trial operations, including start-up, conduct, and close-out.
• Ability to work onsite in Tarrytown, NY, or Warren, NJ.

Nice to have

• Cell therapy experience.
• People management experience.

Culture & Benefits

• Science-driven environment focused on developing life-changing medicines.
• Inclusive workplace and equal opportunity employment.
• Competitive total rewards package that may include annual bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during the recruitment process where required.