Associate Director, Bioanalytical Development (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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
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.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →