Entrada Therapeutics · 18 hours ago
Associate Director, Clinical Biomarkers
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$173K/yr - $206K/yr
6+ years expEntrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients with innovative medicines. The Associate Director, Clinical Biomarkers will lead the development and execution of biomarker activities to support ongoing and new clinical trials, ensuring effective project management and collaboration with internal teams and external partners.
BiotechnologyEmergency MedicineGeneticsHealth CareMedical
Responsibilities
Lead internal clinical biomarker initiatives in the development, transfer, and execution of stage-appropriate biomarker assays for clinical development
Effectively manage on-going activities for biomarker testing and identify technology solutions to support ongoing and planned clinical trials
Demonstrate an established depth and/or breadth of expertise in biomarker assays and provide strong technical guidance; managing the assay development/transfer and oversee fit-for-purpose validation at selected vendors
Contribute to biomarker-related sections of clinical study protocols and health authority submission document, where applicable
Operationalize biomarker tests and ensure results are delivered and archived per clinical development needs
Collaborate with Program Team Leaders, Regulatory, and Medical Directors in the review of clinical protocols, investigator training documents, lab manuals, clinical sample analysis, and regulatory submission activities for clinical development
Partner with Discovery and Non-clinical Development teams in the evaluation and development of clinical biomarker assays and vendor selection for early projects
Manage, identify, and communicate risks to stakeholders in a clear and timely fashion
Manage and guide junior level staff for successful assay development and execution within the biomarker function
Actively engage with industry professionals via attendance and delivery of presentations in conferences, workshops, focus groups, and literature/publications to guide best practices for biomarker development and clinical implementation
Qualification
Required
Ph.D. with 6 + years of relevant experience or Master's in a scientific discipline with 8+ years relevant experience
Previous experience defining and executing 'fit-for-purpose' clinical biomarker assays to address key scientific and clinical questions
Broad understanding of FDA and EMA requirements for biomarker regulatory sections
Extensive understanding in developing, performing, and optimizing ligand binding assay technologies (e.g. ELISA, MSD) and molecular assays (e.g. qPCR, ddPCR, western blot) and related software for data analysis
Experience in outsourcing and managing activities at CROs (e.g. managing timelines and technical troubleshooting) and overseeing development and validation of clinical biomarker assays in a GLP and GCP(GXP) environment
Strong verbal and written communication and presentation skills
Strong interpersonal skills and knowledge of intercultural differences; adept at working across multiple functions to drive decision making
Experience working in a fast-paced, cross-functional environment with multiple competing priorities
Benefits
Comprehensive health, dental and vision coverage
Life and disability insurance
401(k) match
Paid, gender-inclusive parental leave
Holistic support for your health and well-being
Education reimbursement
Discretionary time off
Commuting benefits aligned to your working model
Company
Entrada Therapeutics
Entrada Therapeutics is a developer of novel therapeutics intended to treat devastating diseases.
51-200 employees
H1B Sponsorship
Entrada Therapeutics 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 (7)
2024 (14)
2023 (4)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$301.6MKey Investors
Wellington Management
2024-06-24Post Ipo Equity· $100M
2022-12-08Post Ipo Equity· $26M
2021-10-29IPO
Leadership Team
Dipal Doshi
Chief Executive Officer
Leo Qian
Co-Founder
Recent News
BioWorld Financial Watch
2026-01-11
2025-12-17
Company data provided by crunchbase