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21 час назад

Associate Director, Clinical Science (Oncology)

172 100 - 215 150$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Associate Director, Clinical Science (Oncology) (early cancer detection/cfDNA IVD): Designing and executing rigorous clinical studies for an early cancer detection and cell-free DNA diagnostics portfolio with an accent on clinical strategy, regulatory submissions, and high-quality data delivery. Focus on overseeing real-time clinical data reviews, managing CRO and investigator relationships, analyzing complex data, and driving outcome-focused decisions across clinical programs.

Location: US Remote; other listed location: US - MA.

Salary: $172,100–$215,150 USD annually.

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

  • Develop clinical study concepts, designs, objectives, endpoints, eligibility criteria, assessment schedules, and research plans for early cancer detection and cfDNA IVD programs.
  • Author protocols and clinical sections for regulatory correspondence and IDE, IND, and NDA submissions; support health authority interactions.
  • Lead protocol training, CRF design, study manuals, site selection, site initiation visits, investigator meetings, trial registration, and results reporting.
  • Oversee real-time clinical data reviews, CRO activities, safety reports, clinical monitoring, interim analysis planning, and Data Safety Monitoring Board or Steering Committee meetings.
  • Build strategic relationships with KOLs, clinical sites, consortiums, senior leaders, and cross-functional partners; support advisory boards and scientific presentations.
  • Provide data-backed clinical timeline updates, develop SOPs, analyze complex data, and ensure HIPAA/PHI compliance and training completion.

Requirements

  • Ph.D., RN, MS, or B.S. in a scientific field; an advanced degree such as MS, PharmD, MD, or PhD is preferred.
  • 8–10+ years of clinical research experience, including 3–5+ years in a management role.
  • Experience with project management, clinical research execution, and rigorous scientific writing.
  • Deep knowledge of regulatory standards and Good Clinical Practices (GCP) is required.
  • Strong analytical, project management, organizational, interpersonal, oral, and written communication skills.
  • Ability to work cross-functionally, exercise data-driven judgment, escalate issues, solve ambiguous problems, and deliver actionable clinical outcomes.
  • Proficiency with Google Workspace and Microsoft Office suites.

Nice to have

  • Experience in oncology and early cancer detection is highly preferred.
  • Experience with In Vitro Diagnostics (IVD) is a plus.

Culture & Benefits

  • Remote work in the United States.
  • Medical, dental, vision, life, and disability plans for eligible employees and dependents.
  • Free testing for employees and immediate family members, plus fertility care benefits.
  • Pregnancy and baby bonding leave, 401(k) benefits, commuter benefits, and an employee referral program.
  • Fast-paced environment focused on ownership, precision, cross-functional collaboration, and improving patient care.

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