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2 дня назад

Director, Global Clinical Development (CNS)

209 599 - 313 375$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
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
Director, Global Clinical Development (CNS): Designing and overseeing global clinical research programs and protocols for CNS and Digital Medicine drug and medical device candidates with an accent on clinical safety, efficacy, regulatory readiness, and product value. Focus on translating preclinical research into development plans, interpreting Phase I–IV results, leading regulatory filings, and governing CRO and vendor relationships.

Location: Princeton, NJ or Rockville, MD offices, United States

Salary: $209,599–$313,375 per year, plus incentive opportunity

Company

hirify.global develops global healthcare products through clinical research, drug development, and commercialization programs.

What you will do

  • Design and oversee clinical research programs and protocols for CNS and Digital Medicine products under GCP.
  • Develop global development and commercialization plans covering first-in-human, proof-of-mechanism, registrational, and post-approval trials.
  • Evaluate clinical safety, efficacy, medical usefulness, and value across different stages of development.
  • Interpret and communicate Phase I–IV investigation results and act as signatory on NDA submissions and clinical study and safety documents.
  • Provide strategic oversight of vendor and CRO relationships, including clinical input into governance committees.
  • Lead and support regulatory filing activities by shaping clear and persuasive written and verbal communications.

Requirements

  • MD or DO, preferably with a background in psychiatry or neurology; other clinical or scientific doctorates may be considered in exceptional circumstances with clinical support.
  • At least 6 years of experience in the pharmaceutical industry or academic translational clinical research, depending on the nature of the experience.
  • Advanced understanding of drug development principles, clinical trial implementation, management, and reporting.
  • Experience leading, managing, and motivating internal staff, external investigators, or consultants.
  • Knowledge of global regulatory requirements and related disciplines including biostatistics, clinical pharmacology, data management, medical writing, and health value creation.
  • Ability to work from the Princeton, NJ or Rockville, MD offices and willingness to travel internationally approximately 30% of the time, including weekends.

Nice to have

  • Psychiatry or neurology specialization and prior direct or indirect management experience.
  • Supplementary degree such as a PhD, MPH, or MBA.
  • Experience with successful regulatory filings, financial assessment, project budgeting, market research, and commercialization strategies.

Culture & Benefits

  • Collaborative and innovative environment focused on accountability, strategic thinking, patient centricity, impactful communication, and respectful collaboration.
  • Comprehensive medical, dental, vision, and prescription drug coverage.
  • Company-provided life, accidental death and dismemberment, short-term disability, and long-term disability insurance.
  • Tuition reimbursement, student loan assistance, and a generous 401(k) match.
  • Flexible time off, paid holidays, and paid leave programs.

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