Overview In this role you lead clinical-stage bioanalytical strategy at Scholar Rock, guiding PK/PD, biomarkers, and immunogenicity assays across Phase 1-3 programs. You will oversee outsourced bioanalysis, ensure regulatory readiness, and partner with Discovery, Clinical Sciences, Regulatory, and other teams to align bioanalytical work with development plans. Your leadership will shape dose selection and development strategy while staying ahead of evolving regulatory expectations. You thrive in a fast-paced, cross-functional environment and drive high-impact analytics for rare neuromuscular diseases.
Responsibilities- Provide scientific and strategic leadership for clinical-stage bioanalytical assays (PK, PD, biomarkers, immunogenicity).
- Oversee assay validation, study conduct, data interpretation, and regulatory compliance for clinical studies.
- Execute integrated bioanalytical strategies supporting Phase 1 through Phase 3 programs.
- Manage outsourced bioanalysis at CROs, including method transfer, validation, and data delivery.
- Support vendor selection, start-up, monitoring, and risk mitigation for bioanalytical vendors.
- Author and review bioanalytical sections of regulatory documents (protocols, CLIN reports, BLAs, responses).
- Interpret and integrate PK/PD/biomarker/immunogenicity data to inform dose and strategy.
- Provide SME support for regulatory inspections and inspection-readiness in clinical bioanalysis.
- Present strategies, updates, risks, and recommendations to teams and senior leadership.
- Stay current with emerging bioanalytical technologies and regulatory expectations.
Key requirements- PhD in biochemistry, immunology, pharmaceutical sciences, or related discipline with 7+ years of industry experience.
- Experience supporting biologics or complex modalities across First in Human and other development stages.
- Experience overseeing CROs, external labs, vendors, and academic collaborators.
- Ability to manage multiple priorities and drive complex scientific initiatives in a collaborative environment.
- Passion for rare disease research and translating science into patient benefit.
- collaborative
- independent
- strong communication
- bioanalytical assay development and validation
- pharmacokinetic (PK) and pharmacodynamic (PD) analyses
- biomarker and immunogenicity assays
