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15 часов назад

Project Manager (Biotechnology)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
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
Project Manager (Biotechnology) (Drug Development): Driving integrated program plans for an acute pain asset advancing toward NDA submission and U.S. launch with an accent on cross-functional coordination across regulatory, nonclinical, clinical, CMC/supply, quality, and commercial workstreams. Focus on maintaining critical-path timelines, managing program risks and resources, and translating development strategy into execution.

Location: Hybrid in Thousand Oaks, California or San Francisco, California

Company

hirify.global is an early-stage biotechnology company developing non-opioid medicines for pain and pain-related syndromes.

What you will do

  • Own integrated program plans and timelines across regulatory, nonclinical, clinical, CMC/supply, quality, and commercial workstreams.
  • Maintain scenario-based critical-path timelines from NDA submission through PDUFA and U.S. launch.
  • Coordinate decision-making, resolve program and resource issues, and monitor progress, schedules, and deliverables.
  • Develop program strategy and goals with cross-functional teams while keeping plans aligned with strategic changes.
  • Assess risks, communicate their potential impact, and integrate mitigation plans into overall program planning.
  • Manage decision- and action-oriented meeting minutes, information flow, budgets, tracking, and variance management.

Requirements

  • Bachelor’s degree or higher in life sciences or a related discipline.
  • At least six years of experience in biotechnology, pharmaceuticals, healthcare, or a related field, including at least three years in direct drug development project management.
  • Solid understanding of drug development and commercialization.
  • Proficiency in project management principles and tools such as SmartSheet and Excel.
  • Ability to manage multiple priorities in a fast-paced environment with minimal oversight and influence without authority.
  • Strong interpersonal, organizational, written, and verbal communication skills.

Culture & Benefits

  • Science-based, data-driven, patient-focused, and forward-thinking working environment.
  • Opportunity to support an acute pain program through NDA submission and launch.
  • Collaboration with regulatory, clinical, nonclinical, CMC/supply, quality, and commercial stakeholders.
  • Team environment emphasizing solution-oriented problem-solving and continuous learning.

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