Development Bioanalytical Leader for Peptide Biologics

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

JLSa2 in South San Francisco is seeking a Development Bioanalytical Leader to guide bioanalytical strategies from nonclinical to late-stage clinical studies. You will oversee CROs, drive assay development (LBA, LC-MS/MS), and ensure regulatory readiness to support INDs, CTAs, and BLAs.

The role requires leadership across Toxicology, CMC, Clinical Pharmacology, Regulatory Affairs, and Quality, with a focus on delivering robust bioanalytical data for decision-making.

Qualifications

• Ph.D. in Pharmaceutical Sciences or Analytical Chemistry with 8+ years in bioanalysis.
• Extensive experience with LBA and LC-MS/MS methods.
• Regulatory submission support experience (INDs/BLAs/CTAs).

Responsibilities

• Lead integrated bioanalytical strategies to support nonclinical and clinical programs.
• Oversee outsourced CROs for assay development, validation, and data delivery.
• Provide technical oversight of LBA and LC-MS/MS methods across programs.
• Ensure regulatory compliance for bioanalytical sections and submissions.
• Collaborate with Clinical Pharmacology, Toxicology, Regulatory Affairs, and Quality.

Skills

LBA expertise

LC-MS/MS

PK & ADA knowledge

Regulatory submissions

Cross-functional leadership

Education

Ph.D. in Pharmaceutical Sciences or Analytical Chemistry

Tools

Phoenix WinNonlin

Job description

JLSa2 in South San Francisco is seeking a Development Bioanalytical Leader to guide bioanalytical strategies from nonclinical to late-stage clinical studies. You will oversee CROs, drive assay development (LBA, LC-MS/MS), and ensure regulatory readiness to support INDs, CTAs, and BLAs.

The role requires leadership across Toxicology, CMC, Clinical Pharmacology, Regulatory Affairs, and Quality, with a focus on delivering robust bioanalytical data for decision-making.