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12 дней назад

Director Clinical Development & Medical Affairs (MedTech)

180 000 - 243 000$
Формат работы
hybrid
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
Director Clinical Development & Medical Affairs (MedTech): Leading global clinical development and medical affairs for healthcare products, shaping evidence strategies, clinical studies, claims, and portfolio decisions with an accent on scientific rigor, regulatory compliance, and real-world evidence. Focus on building clinical capabilities, overseeing pre-market and post-market studies, developing external clinical networks, and translating evidence into defensible product claims.

Location: Hybrid in Libertyville, Illinois, US; minimum four days per week in the office

Salary: $180,000–$243,000 yearly, plus eligibility for the corporate bonus plan

Company

hirify.global is an independent, employee-owned healthcare products company developing, manufacturing, and marketing products for ostomy care, continence care, and critical care worldwide.

What you will do

  • Lead the global Clinical Development and Medical Affairs organization and establish its strategic direction.
  • Build evidence roadmaps for products, platforms, and therapy areas, including clinical questions, outcomes, endpoints, and study sequencing.
  • Own pre-market and post-market device studies, including protocols, statistical approaches, investigators, sites, budgets, timelines, CROs, and data quality.
  • Develop real-world evidence capabilities using registries, observational studies, patient-reported outcomes, secondary data, and post-market clinical follow-up.
  • Partner with R&D, Marketing, Regulatory, Legal, Human Factors, Market Access, and New Ventures to develop clinically meaningful and defensible claims.
  • Build clinical networks, guide KOL and advisory board strategy, set publication and congress plans, and represent hirify.global in scientific forums.

Requirements

  • Bachelor’s degree and 12–15 years of related experience.
  • Experience building or substantially strengthening evidence strategies, not only executing studies.
  • Experience designing and overseeing pre-market and post-market device studies through completion.
  • Working command of GCP, ISO 14155, FDA, and EU MDR clinical requirements.
  • Experience with real-world evidence, clinical claims, peer-reviewed publications, or changes in clinical practice.
  • At least 3 years of people leadership experience and the ability to engage with clinicians, researchers, and senior business leaders.

Nice to have

  • MD, PhD, PharmD, DNP, advanced nursing or clinical degree, MS, or MPH combined with deep clinical development experience.
  • Experience with products used in chronic care or other patient-managed conditions.

Culture & Benefits

  • Hybrid work environment with regular office collaboration in Libertyville.
  • Medical, prescription, dental, vision, disability, life, wellbeing, and spending or savings account benefits.
  • Paid parental and caregiver leave, statutory leave programs, paid holidays, vacation, and sick days.
  • 401(k) retirement savings plan with auto-enrollment, Roth contributions, vesting, and eligible safe-harbor matching contributions.
  • Education assistance, adoption assistance, voluntary benefits, and corporate bonus eligibility.

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