Manager, Biomarkers and Bioanalytical Operations

Role Overview

The Biomarker and Bioanalytical Operations Study Manager leads PK, ADA, and biomarker execution across clinical studies, partnering with study teams and CROs to deliver high-quality data on time. This role is critical to achieving key study endpoints and advancing programs through drug development and reports to the Head of Biomarker and Bioanalytical Operations.

What You Will Do

Serve as the primary Biomarker and Bioanalytical Operations lead for internal teams and external partners across Phase 1–4 studies, lead end-to-end operational execution of biomarker and bioanalytical activities, and implement clinical biomarker and bioanalytical strategies for early- and late-stage programs.

Why It Might Be a Fit

You excel in fast-paced clinical development environments dedicated to advancing new therapies to patients. Your expertise in scientific operations, GCLP, and CRO management enables effective collaboration across internal teams and external laboratory partners.

Requirements

• Advanced degree (PharmD or PhD) with 2+ years of relevant industry experience
• Good knowledge of phase I-IV clinical study operations as it pertains to specialty testing (PK, ADA, Biomarkers)
• Experience working with contracted central labs and biomarker/bioanalytical testing labs including sample management, data management, testing requirements and timelines
• Experience reviewing clinical protocols, ICFs, SOW, and contracts
• Experience obtaining contracts and an understanding of Master Agreements and associated contracts
• Experience working within GCP, GLP, & GCLP guidelines

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation