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7 дней назад

Sr. Director/VP Clinical Development and Medical Monitoring

250 000 - 375 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior/director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Мэтч & Сопровод

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Описание вакансии

Текст:
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TL;DR
Sr. Director/VP Clinical Development and Medical Monitoring (Clinical Development/Medical Monitoring): Leading Phase I–III clinical development strategies and medical monitoring for small-molecule therapies in inflammatory, metabolic, and cardiovascular diseases with an accent on clinical strategy, safety, regulatory requirements, and cross-functional execution. Focus on coordinating global clinical trials, managing CROs and pharmacovigilance activities, engaging FDA experts and KOLs, and delivering differentiated development programs.

Location: San Francisco Bay Area, based in Newark, California; in-office work required

Salary: $250,000–$375,000 per year, depending on qualifications and experience

Company

hirify.global is a drug development company creating small-molecule therapeutics for inflammatory, metabolic, autoimmune, and cardiovascular diseases.

What you will do

  • Lead Phase I–III clinical development strategies, life-cycle management, safety responsibilities, and scientific interactions.
  • Manage ongoing clinical studies, timelines, budgets, and the day-to-day activities of clinical CROs.
  • Track clinical research developments and organize data analysis for relevant products.
  • Coordinate clinical medicine, operations, registration, pharmacovigilance, statistics, and cross-functional execution.
  • Engage with FDA review experts, clinical KOLs, physician experts, investors, CROs, and internal research and commercial teams.
  • Develop differentiated clinical strategies based on competitive markets and unmet patient needs.

Requirements

  • Doctor of Medicine degree and a US medical license.
  • At least 8 years of direct experience in pharmaceutical or biotech clinical development, including international drug development.
  • At least 8 years at Director level or above in clinical development.
  • Experience leading global Phase I, II, and III clinical trials and managing patient compliance.
  • Experience developing inflammatory and cardiovascular drugs.
  • Strong knowledge of ICH guidelines, FDA requirements, early research, drug discovery, clinical practice, statistics, and people management.

Culture & Benefits

  • Strategic leadership role within the US clinical development team.
  • Close collaboration with research, commercial, and executive functions.
  • Salary and benefits comparable with peers in the US and China biotech industries.
  • Equal opportunity employment.

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