15 часов назад
Project Manager (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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