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5 часов назад

Associate Medical Director, Clinical Development, Rare Neurology (SMA)

194 000 - 266 750$
Формат работы
onsite
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
Associate Medical Director, Clinical Development, Rare Neurology (SMA) (Clinical Development/SMA): Leading clinical and scientific oversight for spinal muscular atrophy studies from start-up through close-out with an accent on medical monitoring, safety and efficacy interpretation, and regulatory documentation. Focus on coordinating cross-functional study execution, protecting participant safety, maintaining data integrity, and supporting global multicenter clinical development.

Location: Cambridge, Massachusetts, United States; occasional domestic and international travel may be required.

Base salary: $194,000–$266,750 per year, plus eligible short- and long-term incentives.

Company

hirify.global is a mid-sized biotechnology company developing life-changing medicines, including therapies for rare neurological diseases.

What you will do

  • Serve as Study Medical Director for assigned spinal muscular atrophy studies from start-up through conduct, analysis, reporting, and close-out.
  • Develop and review study protocols, amendments, clinical study reports, training materials, regulatory responses, and other clinical documents.
  • Perform medical monitoring and interpret safety, efficacy, and clinical data to support participant safety and evidence-based decisions.
  • Partner with Clinical Operations, Regulatory, Biostatistics, Data Management, Medical Writing, Pharmacovigilance, investigators, vendors, and external experts.
  • Identify and escalate clinical, safety, data-quality, and operational risks while supporting enrollment and protocol adherence.
  • Contribute to regulatory submissions, health authority interactions, investigator meetings, advisory boards, congress presentations, and publications.

Requirements

  • MD, PharmD, and/or PhD with approximately five years of relevant clinical research experience.
  • Hands-on experience with protocol development, medical monitoring, clinical data review, safety and efficacy interpretation, and clinical or regulatory documentation.
  • Working knowledge of GCP, clinical trial design and execution, statistical principles for clinical trial interpretation, and clinical research regulations.
  • Strong organizational, project management, written communication, and verbal communication skills.
  • Experience building relationships with cross-functional and external stakeholders in a global matrix environment.
  • Ability to travel occasionally for scientific meetings, investigator meetings, and clinical site engagement.

Nice to have

  • Experience in neurology and/or rare diseases.
  • Experience supporting global, multicenter interventional clinical studies.
  • Experience with regulatory submissions, clinical study reports, publications, investigator meetings, or advisory boards.

Culture & Benefits

  • Full-time employment in a global, collaborative, and inclusive biotechnology environment.
  • Medical, dental, vision, life, disability, and wellness benefits.
  • Paid vacation, company holidays, personal-significance days, sick time, and parental leave.
  • 401(k) plan with company matching, employee stock purchase plan, and incentive opportunities.
  • Tuition reimbursement of up to $10,000 per calendar year and employee resource group participation.

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