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3 дня назад

Manager, Biological Sciences (Medical Devices)

130 400 - 195 650$
Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
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
Manager, Biological Sciences (Medical Devices): Managing outsourced pre-clinical animal studies for medical device development with an accent on scientific integrity, regulatory compliance, biostatistics, and CRO oversight. Focus on coordinating study design and execution, evaluating statistical data, managing budgets and timelines, and ensuring study results support product safety and efficacy.

Location: Acton, Massachusetts, United States; hybrid. The role includes up to 50% on-site presence at a local animal laboratory and up to 10% domestic travel.

Annual base salary: $130,400–$195,650 for U.S.-based positions. The position may also be eligible for incentive compensation.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other subcutaneous drug delivery solutions.

What you will do

  • Develop and manage outsourced pre-clinical animal study plans with R&D, Regulatory, Quality, engineering, and clinical teams.
  • Act as the primary CRO liaison, coordinating protocols, approvals, shipments, data transfer, timelines, and study execution.
  • Review study protocols, endpoints, experimental designs, sample sizes, statistical power, and biostatistical results.
  • Manage study budgets, vendor contracts, resource allocation, cost tracking, and CRO negotiations.
  • Ensure compliance with FDA requirements, ISO 10993, animal welfare regulations, GLP/non-GLP requirements, and internal SOPs.
  • Lead internal review meetings, communicate risks and outcomes to stakeholders, and provide recommendations based on study data.

Requirements

  • At least a master’s degree in a scientific, biomedical, or engineering field.
  • At least 3 years of experience in pre-clinical research or laboratory animal management, preferably in medical devices.
  • Strong background in biostatistics, experimental design, and interpretation of pre-clinical data.
  • Ability to lead internal review meetings and provide actionable recommendations based on study data.
  • Ability to manage multiple priorities in a fast-paced innovation environment.
  • Strong communication and collaboration skills across diverse teams.
  • Strong project management, budgeting, and negotiation skills.
  • Ability to work in a hybrid arrangement, including up to 50% on-site presence at a local animal laboratory and up to 10% domestic travel.

Nice to have

  • PhD in a relevant scientific discipline or DVM/VMD.
  • AALAS certification.
  • At least 5 years of experience in pre-clinical research or laboratory animal management, preferably in medical devices.
  • Experience managing outsourced studies and vendor relationships.

Culture & Benefits

  • Full-time employment in a performance-driven medical device organization.
  • Medical, dental, and vision insurance.
  • 401(k) with company match.
  • Paid time off and employee wellness programs.

Hiring process

  • The posting remains open until the position is filled.
  • Submit an application online through the hirify.global Careers site.

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