Director, Bioanalysis & DMPK Strategy

Beacon Hill Staffing Group; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

Beacon Hill Staffing Group in Boston seeks a Director, Bioanalysis and DMPK to lead the bioanalytical and ADME strategy across preclinical and clinical development for our di-siRNA platform for treating severe neurological disease.

The role oversees method development, validation, and application, manages CROs, drives PK/PD modeling, and contributes to regulatory submissions while staying current with regulatory trends in oligonucleotide bioanalysis. This is a senior, hands-on leadership role.

Qualifications

• PhD (preferred) or MS in bioanalytical chemistry, pharmacology, biochemistry, or related field.
• 10+ years of experience in regulated bioanalysis and DMPK in biotech/pharma.
• Proven IND-enabling studies and clinical trial support.
• Expertise in ligand-binding assays (ELISA, MSD), LC-MS/MS, immunogenicity assays, and biomarkers.
• Understanding of FDA/global regulatory guidance for bioanalytical assays and DMPK.
• Experience with PK/PD modeling and Phoenix WinNonlin.
• Knowledge of GLP, SOPs, and QA.
• Experience managing CROs and internal teams.

Responsibilities

• Lead external bioanalytical and ADME activities for nonclinical and clinical programs, including method development, qualification and validation, and sample analysis.
• Serve as the SME for bioanalytical sciences, ensuring data quality and regulatory compliance (GLP, GCP, FDA, EMA).
• Collaborate cross-functionally with discovery, preclinical, clinical, and regulatory teams to align strategies with program timelines and goals.
• Manage relationships with CROs, including oversight of assay transfer, validation, and sample analysis.
• Oversee CROs for in vitro or in vivo ADME studies for regulatory submissions.
• Lead PK/PD modeling for nonclinical and human dose predictions.
• Contribute to writing nonclinical study reports and regulatory submissions (IND, BLA, etc.).
• Stay abreast of emerging technologies and regulatory trends in oligonucleotide bioanalysis.

Skills

ELISA

MSD

LC-MS/MS

PK/PD modeling

CRO management

Regulatory knowledge

GLP/GCP

Biomarker development

DMPK expertise

Pharmacology background

Education

PhD in bioanalytical chemistry or related field

Tools

Phoenix WinNonlin

Job description

Beacon Hill Staffing Group in Boston seeks a Director, Bioanalysis and DMPK to lead the bioanalytical and ADME strategy across preclinical and clinical development for our di-siRNA platform for treating severe neurological disease.

The role oversees method development, validation, and application, manages CROs, drives PK/PD modeling, and contributes to regulatory submissions while staying current with regulatory trends in oligonucleotide bioanalysis. This is a senior, hands-on leadership role.