Senior Bioanalytical Scientist, Clinical Programs Lead

Scholarrock; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Scholar Rock seeks a Principal Scientist, Bioanalytical Specialist to lead clinical-stage bioanalysis across programs. You will represent the bioanalytical team at study meetings and oversee CROs, assay validation, sample analysis and data delivery to support development from Phase 1 to Phase 3, collaborating with cross-functional partners.

You will provide SME input on PK/PD, biomarkers, and immunogenicity, ensure regulatory readiness, and stay ahead of evolving bioanalytical technologies to

Qualifications

• PhD with 7+ years in biopharmaceutical industry.
• Experience supporting biologics or complex modalities in multiple clinical stages.
• Scientific oversight of CROs, external labs and vendors.
• Ability to manage multiple priorities in a fast-paced environment.
• Passion for rare disease research and translating science into patient benefit.

Responsibilities

• Provide SME input for clinical-stage bioanalytical assays (PK/PD, biomarkers, immunogenicity).
• Oversee assay validation, sample analysis, data interpretation and regulatory compliance.
• Lead outsourced bioanalysis at CROs and partner labs, including transfers and issues.
• Support vendor selection, contracting, start-up, monitoring and risk mitigation.
• Prepare bioanalytical sections of protocols, study reports, BLAs and responses.

Skills

Bioanalytical leadership

CRO management

Cross-functional collaboration

Regulatory knowledge

Education

PhD in biochemistry/immunology/pharmaceutical sciences

Job description

Scholar Rock seeks a Principal Scientist, Bioanalytical Specialist to lead clinical-stage bioanalysis across programs. You will represent the bioanalytical team at study meetings and oversee CROs, assay validation, sample analysis and data delivery to support development from Phase 1 to Phase 3, collaborating with cross-functional partners.

You will provide SME input on PK/PD, biomarkers, and immunogenicity, ensure regulatory readiness, and stay ahead of evolving bioanalytical technologies to