Senior Scientist II, Translational Science

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

This lab-based role is an exciting opportunity to join a highly collaborative team as a bioanalytical expert (pharmacokinetic, immunogenicity, and pharmacodynamic/target-engagement assays) in the Translational Science team at Scholar Rock. You will utilize your expertise in the development of bioanalytical strategies and leading bioanalytical assay development, qualification, and validation projects to characterize the PK/PD relationship of antibody therapeutics and generate decision enabling bioanalytical data. In this role, you will have a high impact across the Scholar Rock portfolio from early discovery to clinical stage programs, supporting our neuromuscular, cardiometabolic, fibrosis, and early research projects. Additionally, you will work collaboratively with the Scholar Rock Research and Development teams, and you will also serve as the bioanalytical representative on early research project teams. You will also train, mentor, and coach other scientists in the group and lead the externalization and oversight of bioanalytical assays at CROs.

Position Responsibilities:

• Independently execute the development of a broad range of bioanalytical assays, including pharmacokinetic, pharmacodynamic/target-engagement, immunogenicity (ADA and NAb), and cell-based assays to support preclinical and clinical studies. 
• Independently lead and contribute to experimental design, planning, and execution of bioanalytical assay projects. Responsibilities also include assay lifecycle management.
• Expertise in a range of bioanalytical platforms/technologies, including ELISA, MSD, LC-MS/MS.
• Provide bioanalytical expertise in the bioanalytical aspects of preclinical and clinical studies 
• Lead bioanalytical strategy workstreams for assigned projects with the Clinical Pharmacology team.
• Lead bioanalytical support and execution for preclinical studies, including in vivo pharmacology studies in animal models as well as non-GLP and GLP Tox studies and generate IND-enabling, high quality bioanalytical data and contribute to the reports.
• Contribute to regulatory (e.g., INDs), nonclinical, and clinical documents. 
• Author and review SOPs. 
• Independently drives self and motivates team to strive to exceed project goals and milestones. 
• Management of external labs (CROs), including vendor selection, technical oversight, budgets, and maintaining project timelines.
• Maintain critical reagents and sample inventories 

Candidate Requirements:

• PhD in biology related discipline with 5+ years of relevant industry experience or BS/MS degree in biology or related discipline with 10+ years of relevant industry experience.
• Proficient with Microsoft Office, GraphPad Prism, Softmax Pro GXP, and statistical software.
• Knowledge of relevant regulatory (e.g., FDA and EMA) guidelines and local/regional requirements.
• Demonstrated ability to work in fast-paced, dynamic setting and balancing competing priorities.
• Strong organization skills and process oriented.
• Excellent communication skills (oral and written).

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.