Über diese Principal Scientist, Bioanalytical Specialist Stelle bei Scholarrock
Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.
As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Scholar Rock is seeking an accomplished and highly collaborative leader in clinical bioanalysis to join the Bioanalytical Sciences team as Principal Scientist, Bioanalytical Specialist to provide scientific and operational leadership across our clinical stage programs.
Reporting to the Head of Bioanalytical Sciences, this individual will serve as a bioanalytical subject matter expert for our clinical stage programs, by representing the bioanalytical team at clinical study team meetings and providing oversight of clinical bioanalysis activities at CROs, including assay validation, sample analysis, data delivery, issue resolution, and inspection readiness, supporting strategic initiatives within the Bioanalytical and Preclinical Sciences teams. The Principal Scientist will partner cross-functionally with key parters in Discovery, Biomarker Development, Clinical Pharmacology, Clinical Sciences, Clinical Operations, and Regulatory to align bioanalytical strategy and execution with clinical development plans, regulatory expectations, and key program decisions. This individual will establish priorities and drive bioanalytical execution across multiple clinical programs in a dynamic, fast-paced environment.
The successful candidate will have demonstrated the ability to lead bioanalysis across all clinical stages, CRO management, and issue resolution. They will collaborate cross-functionally and provide scientific, strategic, and operational leadership for outsourced bioanalytical activities supporting Scholar Rock’s clinical-stage programs.
Position Responsibilities
- Provide scientific and strategic leadership for clinical-stage bioanalytical assays, including pharmacokinetic (PK), pharmacodynamic (PD), biomarker, and immunogenicity assays.
- Serve as the clinical bioanalysis subject matter expert for assay validation, study conduct, sample analysis, data interpretation, and regulatory compliance.
- Execute integrated bioanalytical strategies that support first in human Phase 1 through Phase 3 clinical development programs.
- Provide scientific and operational oversight of outsourced clinical bioanalysis at CROs and partner laboratories, including method transfer, validation, sample analysis, troubleshooting, and data delivery.
- Support vendor selection, contracting, study start-up, performance monitoring, and risk mitigation for bioanalytical vendors.
- Author, review, and provide SME input for bioanalytical sections of clinical and regulatory documents, including protocols, lab manuals, clinical study reports, investigator brochures, BLAs, and responses to health authority questions.
- Contribute to interpretation and integration of PK, PD, biomarker, and immunogenicity data to inform dose selection, development strategy, and program decision-making.
- Provide SME support for regulatory inspections, audits, and inspection-readiness activities related to clinical bioanalysis.
- Present bioanalytical strategies, study updates, risks, and recommendations to project teams, governance committees, and senior leadership.
- Stay current with emerging bioanalytical technologies, industry trends, and evolving regulatory expectations to continuously strengthen organizational capabilities.
