project managementgcpregulatory affairsoncologyclinical researchclinical trialsscientific writingcfdnain vitro diagnosticsearly cancer detection
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Зарплата и рынок
$172к-215к/год
$200к$240кмедиана$270к
По похожим ролям (35) ~ $240к/год
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Чётко очерченная руководящая роль в биотехе с фокусом на раннее выявление рака, самостоятельным ведением значимых исследований и регуляторной работой.
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Большая зона ответственностиРанняя диагностика ракаЗаметная биотех-компания
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Описание вакансии
Текст:
Hirify AI/Оригинал
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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