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4 часа назад

Associate Director, Bioanalytical Development (Pharma)

177 500 - 232 000$
Формат работы
hybrid
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

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TL;DR
Associate Director, Bioanalytical Development (Pharma): Leading bioanalytical strategy and delivery for preclinical and clinical programs spanning small molecules and biologics with an accent on PK/TK, LC–MS/MS, immunogenicity, and regulatory-ready documentation. Focus on managing CRO execution, designing fit-for-purpose assay strategies, ensuring traceable analysis-ready data, and standardizing workflows across programs.

Location: Hybrid, requiring 3 days per week in office, primarily in the New York City or Boston metro areas; applicants in the Research Triangle, NC, and San Francisco Bay Area may also be considered. Applicants must reside in these locations or be willing to relocate.

Total compensation range: $177,500–$232,000, plus equity, comprehensive benefits, and perks.

Company

hirify.global is a technology- and AI-driven pharmaceutical company building platforms and capabilities to accelerate drug development and clinical trials.

What you will do

  • Lead bioanalytical strategy and delivery for assigned preclinical and clinical programs across small molecules and biologics.
  • Define assay plans and validation approaches for PK/TK, metabolites, biologics bioanalysis, and immunogenicity.
  • Manage CROs and specialty labs, including partner selection, scope definition, timelines, quality, performance, and budget.
  • Oversee protocols, method validation, sample analysis, data review, final reports, and submission-ready documentation.
  • Coordinate with Clinical Pharmacology, Clinical Operations, DMPK/Nonclinical, Regulatory Affairs, Biostatistics, and Data Science.
  • Standardize bioanalytical workflows, templates, tracking, reporting conventions, and analysis-ready data across programs.

Requirements

  • PhD in a relevant field with 7+ years of bioanalytical experience in biopharma, including clinical-stage support, or a relevant undergraduate degree with 10+ years of experience.
  • Experience leading bioanalytical strategy and execution for preclinical and clinical programs involving small molecules and biologics.
  • Deep LC–MS/MS expertise for PK/TK, troubleshooting, and ISR.
  • Working knowledge of biologics bioanalysis, immunogenicity approaches including ADA/NAb, and bioanalytical regulatory expectations.
  • Experience leading CRO/vendor execution and producing submission-quality documentation.
  • Ability to work cross-functionally in a fast-paced environment and translate technical details into program-relevant recommendations.

Nice to have

  • Experience participating in clinical study teams and balancing vendor selection, development speed, assay quality, and method applicability.
  • Familiarity with GCP/GCLP expectations and audit or inspection readiness.
  • Experience with sample logistics, stability, chain of custody, and data flow into filings.

Culture & Benefits

  • Hybrid work model with office collaboration three days per week.
  • Equity, comprehensive benefits, and generous perks.
  • Mission-driven work focused on bringing new medicines to patients faster and more efficiently.
  • Inclusive, diverse, and equal-opportunity workplace.

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