Director/Sr. Director, Clinical Pharmacology

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the 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.

About the role

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.

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 IV to SC transition dosing plans
• 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

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
• Strong background in quantitative drug development and a desire to work collaboratively across different functional areas, as well as with external vendors and partners
• Experience in modeling and simulation of pharmacokinetic, pharmacodynamic, and exposure-response analyses, including expertise with population modeling
• Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology assessing the clinical relevance
• Strong interpersonal writing and presentation skills, as well as the ability to function in a team environment are essential
• Understands the drug development process from pre-IND through BLA
• Highly organized, outcome-oriented, self-motivated performer

Pay

$225,000 - $315,000 a year