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Scholar Rock

Posted 1 month ago

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Director/Sr. Director, Clinical Pharmacology

Cambridge, MAOn-siteFull-time

AI Summary

Director/Sr. Director of Clinical Pharmacology leads clinical pharmacology strategies and PK/PD modeling/simulation to guide development and dosing of biologic therapies, including monoclonal antibodies, for rare neuromuscular diseases.

About this role

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. 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 at ScholarRock.com and follow @ScholarRock on X 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.

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 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

    • 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
  • 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

    • Skills

    Clinical PharmacologyExposure-Response AnalysisIV To SC Transition DosingModel-informed Drug Development (MIDD)Monoclonal AntibodiesPharmacometricsPK/PD ModelingPopulation PK

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