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2 дня назад

Vice President Clinical Development

Формат работы
hybrid
Тип работы
fulltime
Грейд
head
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
Vice President Clinical Development (Medical Devices): Defining and executing enterprise clinical development strategy across a global portfolio with an accent on regulatory compliance, evidence generation, governance, and organizational leadership. Focus on guiding programs from early development through approval and post-market lifecycle management, optimizing complex budgets and resources, and leading strategic decisions across clinical, scientific, regulatory, and operational functions.

Location: Sunnyvale, California; hybrid arrangement with at least 60% or 24 hours of the work week onsite. Tuesdays and Thursdays are key onsite days, and the schedule may exceed the 60% requirement.

Company

hirify.global develops products and clinical programs focused on advancing cancer detection and related health technologies.

What you will do

  • Define and execute clinical development strategy across the portfolio, including multi-year outcomes, evidence generation, development priorities, scientific integrity, and regulatory compliance.
  • Oversee governance and delivery of clinical studies across all phases, making high-stakes decisions across clinical, scientific, regulatory, operational, and financial considerations.
  • Partner with the CMO and Research, Regulatory Affairs, Medical Affairs, and Commercial leaders on integrated development strategies and lifecycle plans.
  • Establish the Clinical Development operating model, governance frameworks, decision processes, and organizational capabilities.
  • Represent Clinical Development in executive, board, regulatory, scientific, and strategic partner engagements and contribute to major regulatory submissions.
  • Build and develop a multi-layer leadership organization while managing budgets, workforce planning, resources, organizational change, diversity in clinical research, study-design innovation, and emerging technologies.

Requirements

  • Advanced degree such as MD, PhD, PharmD, or equivalent in life sciences, health sciences, or a related discipline, with 20+ years of progressive clinical research or development experience; an MD is highly preferred.
  • At least 10 years of senior leadership experience overseeing global clinical programs and cross-functional teams.
  • Track record leading programs from early development through regulatory approval and post-market lifecycle management.
  • Deep understanding of global regulatory frameworks, clinical trial governance, and operational best practices.
  • Ability to provide strategic guidance, influence executive decisions, and represent the organization externally.
  • Experience managing large, complex budgets and multi-regional teams.
  • Knowledge of regulated medical device and clinical study environments, including IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11, ICH E6/GCP, ISO 20916, FDA 21 CFR Part 50, Part 54, and Part 56.
  • Exceptional strategic leadership, organizational vision, executive communication, negotiation, collaboration, innovation, accountability, financial acumen, scientific excellence, data integrity, ethical research practices, emotional intelligence, integrity, and executive presence.
  • Frequent domestic and international travel is required for governance meetings, regulatory interactions, and strategic partnership engagements.

Culture & Benefits

  • Flexible work arrangement combining office and home work, subject to the onsite requirement and team and business needs.
  • Flexible time off or vacation, medical, dental, and vision coverage.
  • 401(k) retirement plan with employer match and well-being programs.
  • Potential eligibility for annual bonus and other incentives in addition to base pay.
  • Equal employment opportunity, reasonable accommodations, and a drug-free workplace.

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