Director/Sr. Director, Clinical Pharmacology jobs in United States
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Scholar Rock · 1 month ago

Director/Sr. Director, Clinical Pharmacology

Scholar Rock is a biopharmaceutical company focused on developing innovative therapies for serious diseases. They are seeking a Director/Senior Director of Clinical Pharmacology to lead clinical pharmacology strategies, execute modeling and simulation plans, and contribute to regulatory discussions and clinical study designs.

BiopharmaBiotechnologyMedicalTherapeutics
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H1B Sponsor Likelynote

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

Qualification

Clinical pharmacologyModelingSimulationPharmacokineticsPharmacodynamicsSubcutaneous drug developmentInterpersonal skillsOrganizational skillsSelf-motivated

Required

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
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

Preferred

Experience in subcutaneous drug development and IV to SC bridging is highly desired

Company

Scholar Rock

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Scholar Rock is a biopharmaceutical company that develops and discovers new medicines and treatments for the serious diseases.

H1B Sponsorship

Scholar Rock has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2021 (4)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$743M
Key Investors
InvusFidelityARCH Venture Partners
2024-10-08Post Ipo Equity· $300M
2023-10-11Post Ipo Equity· $85M
2022-06-17Post Ipo Equity· $205M

Leadership Team

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Jay Backstrom
Chief Executive Officer
Company data provided by crunchbase