Clinical Bioanalysis Lead – Biologics & PK/PD Expert

Scholar Rock, Inc.; Cambridge (MA); Híbrido; USD 175.000 - 225.000; Jornada completa

Descripción de la vacante

Scholar Rock is seeking an accomplished Principal Scientist, Bioanalytical Specialist to lead bioanalytical strategies across multiple clinical programs. You will serve as the SME for PK/PD, biomarker, and immunogenicity assays, and provide oversight of CROs, method transfer, and data delivery in a dynamic, fast-paced environment.

Reporting to the Head of Bioanalytical Sciences, you will partner across Discovery, Clinical Sciences, Regulatory, and Operations to align strategy with development

Formación

• PhD with 7+ years in biopharmaceutical industry.
• Experience supporting biologics across clinical development (FIH to Phase 3).
• Oversight of CROs, external labs, vendors, and collaborators.

Responsabilidades

• Provide scientific and strategic leadership for clinical-stage bioanalytical assays (PK/PD, biomarkers, immunogenicity).
• Serve as SME for assay validation, study conduct, sample analysis, data interpretation, and regulatory compliance.
• Oversee outsourced bioanalysis at CROs and partner labs, including method transfer and data delivery.

Conocimientos

Team leadership

CRO management

Bioanalysis oversight

Regulatory support

Educación

PhD in Biochemistry/Immunology/Pharmaceutical Sciences

Descripción del empleo

Scholar Rock is seeking an accomplished Principal Scientist, Bioanalytical Specialist to lead bioanalytical strategies across multiple clinical programs. You will serve as the SME for PK/PD, biomarker, and immunogenicity assays, and provide oversight of CROs, method transfer, and data delivery in a dynamic, fast-paced environment.

Reporting to the Head of Bioanalytical Sciences, you will partner across Discovery, Clinical Sciences, Regulatory, and Operations to align strategy with development