Associate Director, Clinical Assay Strategy

Job overview

The Associate Director, Clinical Assay Strategy role is onsite in Waltham, MA, and compensation is not specified. The position supports CSL Behring’s clinical bioanalytics and biomarker work for clinical programs. CSL Behring develops therapies for patients across several therapeutic areas. This role sets strategy and provides scientific oversight for bioanalytical and biomarker assays, including external execution and assay transfers. It helps clinical programs progress with reliable, compliant data and supports regulatory submissions, vendor oversight, and cross-functional decisions.

What you'll do

• Develop bioanalytical and biomarker strategies
• provide leadership and mentorship
• advise on assay data quality, regulatory expectations, submission readiness, and risks
• direct assay strategy and implementation
• manage external assay execution and technical transfers
• support vendor selection and governance
• optimize workflows and resources
• interpret data, troubleshoot issues, guide best practices, contribute to regulatory submissions, and represent the organization at scientific meetings.

What we're looking for

Skills & competencies

clinical assay strategy

bioanalytical assays

biomarkers

clinical research

regulatory compliance

vendor oversight

waltham ma

csl behring

scientific leadership

clinical development

Work arrangement

• Weekend coverage required

Benefits & perks

• CSL benefits information is available through the employer’s benefits resource
• specific benefits are not detailed in the posting.

Why this role

Requires postgraduate education, preferably a PhD, and 5–10 years of relevant industry or equivalent academic experience.

About the employer

CSL Behring is hiring for this role. Industry: Surgical Appliance and Supplies Manufacturing. Sector: 33.