Director, Bioanalytical

Scorpion Therapeutics; Burlington (MA); On-site; USD 180,000 - 250,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director of Bioanalytical Sciences to provide strategic, scientific, and operational leadership for development, validation, and execution of bioanalytical strategies across discovery, preclinical, and clinical stages. Responsibilities include leading assay development and transfer, PK/PD and immunogenicity assessments, and oversight of CROs and external labs.

The role requires MS with 9+ years or PhD with 7+ years in bioanalysis, with leadership across Phase

Qualifications

• MS/PhD with extensive bioanalytical experience and leadership.
• Deep LC-MS/MS, biomarker assays, and immunogenicity testing expertise.
• Strong knowledge of GLP/GCLP and ICH M10 guidance.
• Experience managing CROs/external labs and vendor governance.
• Leadership supporting Phase I–III studies and regulatory submissions.

Responsibilities

• Lead bioanalytical assay development, validation, transfer, and execution.
• Oversee PK, PD, immunogenicity, and biomarker assessments.
• Develop phase-appropriate bioanalytical strategies per global regulations.
• Serve as GLOBAL bioanalytical SME on cross-functional teams.
• Oversee external CROs/labs; manage data quality, timelines, budgets.
• Review/interpret bioanalytical data for development/regulatory decisions.
• Author/review INDs, clinical study reports, and bioanalytical reports.
• Build, mentor, and scale bioanalytical teams; drive new technologies.

Skills

Bioanalytical leadership

LC-MS/MS

Biomarker assays

Immunogenicity testing

Regulatory guidance

CRO management

Phase I–III leadership

Team development

Education

MS with 9+ years experience

PhD with 7+ years experience

Job description

What You’ll Do

The Director of Bioanalytical Sciences provides strategic, scientific, and operational leadership for development, validation, and execution of bioanalytical strategies supporting precision peptide therapeutics across discovery, preclinical, and clinical stages.

Key responsibilities:

• Lead bioanalytical assay development, validation, transfer, and execution.
• Lead PK, PD, immunogenicity (ADA/NAb), and biomarker assessments.
• Develop phase-appropriate bioanalytical strategies compliant with FDA, EMA, ICH, and other global requirements.
• Serve as bioanalytical subject matter expert on cross-functional teams (Research, Clinical Development, Clinical Pharmacology, Regulatory Affairs, CMC, Quality).
• Oversee external CROs and laboratory partners (data quality, timelines, budget, operational excellence).
• Review, interpret, and communicate bioanalytical/PK/immunogenicity/biomarker data for development and regulatory decisions.
• Author/review INDs, clinical study reports, bioanalytical reports, and responses to health authority inquiries.
• Build, mentor, and develop bioanalytical teams; identify and implement emerging technologies/best practices.

What You Bring

• MS with 9+ years’ experience or PhD with 7+ years bioanalytical experience in biotech/pharma, including leadership for preclinical/clinical programs.
• Deep expertise in LC-MS/MS, biomarker assays, and immunogenicity testing for peptides/small molecules.
• Proven bioanalytical method development and validation experience.
• Strong knowledge of GLP/GCLP and bioanalytical regulatory guidance (ICH M10).
• Experience managing CROs/external labs (assay transfer, validation oversight, troubleshooting, vendor governance).
• Leadership supporting Phase I–III studies and IND/BLA/NDA support.
• Metabolic disease/obesity/endocrinology/peptide therapeutics experience desirable.
• Excellent communication/data interpretation; people-management and scalable operations building skills.