Head of Bioanalytical Development for Peptide Therapeutics

Valid8 Financial, Inc.; South San Francisco (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

Valid8 Financial, Inc. is seeking a Development Bioanalytical Leader to provide scientific, operational, and regulatory leadership for bioanalytical activities across peptide biologics from nonclinical through late-stage clinical studies.

The role oversees CRO partners, guides LC-MS/MS and LBA strategy, ensures FDA/EMA/ICH alignment, and collaborates with cross-functional teams to enable regulatory submissions and informed development decisions.

Qualifications

• PhD in Pharmaceutical Sciences required.
• 8+ years of bioanalytical experience in biotech/pharma/CRO.
• Expertise in peptide/biologic therapeutics and LBA/LC-MS/MS methods.

Responsibilities

• Develop and execute integrated bioanalytical strategies for nonclinical and clinical programs.
• Lead outsourced bioanalytical activities with CROs, ensure quality and regulatory compliance.
• Provide regulatory expertise for INDs, CTAs, BLAs, and MAAs and support inspections.

Skills

LBA methods

LC-MS/MS

PK/ADA knowledge

Regulatory submissions

Cross-functional leadership

External CRO mgmt

Education

Ph.D. in Pharmaceutical Sciences

Tools

Phoenix WinNonlin

Job description

Valid8 Financial, Inc. is seeking a Development Bioanalytical Leader to provide scientific, operational, and regulatory leadership for bioanalytical activities across peptide biologics from nonclinical through late-stage clinical studies.

The role oversees CRO partners, guides LC-MS/MS and LBA strategy, ensures FDA/EMA/ICH alignment, and collaborates with cross-functional teams to enable regulatory submissions and informed development decisions.