leadershipportfolio managementregulatory affairsclinical researchclinical governanceclinical trialsmedical devicesclinical development
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
Пожаловаться
79
Хорошая вакансия
развернуть
Это четко описанная руководящая роль в компании, работающей над ранним выявлением рака, но требование проводить на месте не менее 60% времени, частые поездки и высокий порог опыта делают условия требовательными.
Кликните для подробной информации
Частые поездкиМного времени в офисеШирокая зона ответственностиОнкологические технологии
Оценка от Hirify AI
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Подключить Plus
Описание вакансии
Текст:
Hirify AI/Оригинал
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.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →