Director, Bioanalysis and DMPK

Beacon Hill; 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

Director, Bioanalysis and DMPK (KK_DMPK) Boston, Massachusetts

Director, Bioanalysis and DMPK

POSITION SUMMARY:

This position will be responsible for the development and execution of the bioanalytical and ADME strategy across all stages of preclinical and clinical development for our Client's di-siRNA platform for treating severe neurological disease. This leader will oversee the development, qualification or validation, and application of bioanalytical methods to support PK, PD, immunogenicity, and biomarker analysis. This role is also responsible for execution of in vitro and in vivo ADME studies to support successful regulatory submissions. The ideal candidate brings deep scientific expertise, operational savvy, and thrives in a fast-paced, entrepreneurial environment.

RESPONSIBILITIES:

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

QUALIFICATIONS:

• PhD (preferred) or MS in bioanalytical chemistry, pharmacology, biochemistry, or related field.
• 10+ years of experience in the biotech/pharmaceutical industry, with a strong background in regulated bioanalysis and DMPK. Experience with oligonucleotides is preferred.
• Proven track record of supporting IND-enabling studies and clinical trials from Phase 1 through late-stage development.
• Expertise in ligand-binding assays (ELISA, MSD, etc.), LC-MS/MS, immunogenicity assays, and biomarker development.
• Understanding of FDA and global regulatory guidance and requirements related to bioanalytical assays and DMPK requirements.
• Experience with PK/PD modeling from discovery through development. Proficient with Phoenix WinNonlin or similar.
• Knowledge of Good Laboratory Practices (GLP), standard operating procedures (SOPs), and stage-appropriate quality assurance.
• Experience managing CROs and internal teams.
• Excellent organizational, presentation, and project management skills.
• Ability to make data-driven decisions and demonstrated flexibility to adapt to modifications in project plans in a fast-paced environment.