Head of Biomarker Development jobs in United States
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Scholar Rock · 4 hours ago

Head of Biomarker Development

Scholar Rock is a biopharmaceutical company focused on developing life-changing therapies for serious diseases. They are seeking a strategic scientific leader to shape and execute the biomarker strategy across their pipeline, enabling translation from discovery through clinical development in neuromuscular and rare diseases.

BiopharmaBiotechnologyMedicalTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Define and drive the biomarker development strategy across preclinical and clinical programs, ensuring alignment with overall portfolio goals
Serve as a translational science thought leader, integrating biomarker approaches into program strategy, clinical development plans, and indication expansion activities
Represent Biomarker Development in cross-functional governance and portfolio planning forums
Lead the design, development, and qualification of fit-for-purpose biomarker assays (fluid, tissue, imaging, molecular, and cellular)
Oversee biomarker implementation in preclinical models and clinical studies, ensuring robust data generation and interpretation
Manage CROs and external collaborators/vendors to deliver high-quality biomarker data
Collaborate with discovery teams to translate preclinical biomarker hypotheses into clinically actionable endpoints
Provide expertise on novel technologies (e.g., immunoassays, LC-MS, SIMOA, RNA-seq, digital pathology, imaging biomarkers, multiparameter flow cytometry)
Contribute to the design of biomarker plans within clinical study protocols, informed consent forms, and statistical analysis plans
Author and review biomarker sections of INDs, CTAs, IBs, CSRs, and other regulatory filings
Present biomarker data and strategy to internal stakeholders, governance committees, external partners, and regulatory agencies

Qualification

Biomarker strategy developmentBiomarker assay developmentTranslational science expertiseBiotech/pharma R&D experienceRegulatory knowledgeCollaboration with CROsLeadership skillsPassion for rare diseasesCommunication skillsInterpersonal skills

Required

PhD in biology, immunology, neuroscience, pharmacology, or related discipline
10+ years of experience in biotech/pharma R&D with a strong track record in biomarker discovery and development, including translational application in clinical trials
Demonstrated leadership in developing and implementing biomarker strategies for rare diseases; experience in neuromuscular disorders strongly preferred
Proven expertise with a range of biomarker platforms (immunoassays, LC-MS, transcriptomics, imaging, flow cytometry, digital pathology, and molecular assays)
Familiarity with bioanalytical and regulatory requirements for biomarker integration in IND-enabling studies and clinical development
Experience managing CROs, external consultants, and collaborative teams
Strong leadership, interpersonal, and communication skills, with the ability to influence across levels and functions
Passion for rare disease research and a commitment to improving patients' lives

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