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:
Scholar Rock is seeking a motivated, energetic, and outstanding individual with experience in clinical pharmacology and pharmacometrics to join our team in developing novel biologic therapies that target protein growth factors in the disease microenvironment. The Director/Senior Director of Clinical Pharmacology, reporting to the Head of Clinical Pharmacology, will have strong quantitative clinical pharmacology skills and hands-on modeling and simulation experience. This individual will be responsible for the analysis and interpretation of PK, PD, and efficacy data to guide the development of biologics including monoclonal antibodies. The ideal candidate will have significant experience in subcutaneous drug development.
Position Responsibilities:
Lead clinical pharmacology strategies across multiple programs at various stages of clinical development
Execute modeling and simulation plans including PK/PD, population PK, and exposure-response analyses to guide clinical trial design, dose selection and optimization
Develop clinical pharmacology plans to bridge IV to SC dosing
Provide pediatric clinical pharmacology expertise and co-lead workstreams related to formulation development and sub-cutaneous route of administration
Apply model-based drug development principles to answer key development questions enabling efficient drug development
Contribute to preparation of regulatory documents and participate in discussions with Regulatory Agencies, with a focus on Model-informed Drug Development (MIDD).
Contribute to clinical protocol design, study execution, data analysis, and writing clinical study reports
Collaborate and mentor bioanalytical and translational team to develop comprehensive preclinical and clinical PK/PD strategy
Candidate Requirements:
PhD in pharmacokinetics or pharmacology
7-10 years of experience in pharma/biotech industry, with proven track record of using clinical pharmacology to guide clinical trial/dosing decision
Proficient knowledge and hands-on experience in all aspects of clinical pharmacology, including modeling and simulation of pharmacokinetic, pharmacodynamic, and efficacy relationships, including expertise with population modeling
Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology assessing the clinical relevance
Experience in subcutaneous drug development and IV to SC bridging is highly desired
Strong interpersonal skills to work effectively in a team setting/matrix-type organization
Understands the drug development process from pre-IND through BLA
Highly organized, outcome-oriented, self-motivated performer
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
