Entrada Therapeutics

👥 101-250💰 $100,000,000 Post-IPO Equity 8 months agoBiotechnology Emergency Medicine Medical Health Care Genetics💼 Private Company

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Entrada Therapeutics is a clinical-stage biopharmaceutical company pioneering a novel approach to treating devastating diseases. We develop Endosomal Escape Vehicle (EEV™) therapeutics, designed for efficient intracellular delivery of proteins, peptides, and nucleic acids, overcoming limitations of traditional large and small molecule therapies. This innovative technology allows us to target previously inaccessible intracellular pathways, advancing a robust portfolio of RNA-, antibody-, and enzyme-based programs for neuromuscular, ocular, metabolic, and immunological diseases. Our lead oligonucleotide programs are in development for Duchenne muscular dystrophy, and we've partnered on a clinical-stage program for myotonic dystrophy type 1. Entrada operates with a strong tech foundation, utilizing technologies such as Drupal 10, Akamai EdgeWorkers, and BunnyCDN Header for our web infrastructure and various other technologies for streamlining internal processes. Our engineering culture fosters collaboration and innovation, valuing a balance between cutting-edge technology and patient-focused results. We pride ourselves on our values of Humanity, Tenacity, Creativity, Collaboration, and Curiosity – these principles guide our work and interactions. We're a dynamic team of experts in therapeutic development and rare diseases, currently employing 101-250 people and headquartered in Boston, MA. With significant funding secured and a growing pipeline of promising therapies, Entrada is poised for continued growth and expansion. We offer a variety of remote work opportunities and employee benefits designed to support a positive work-life balance. Entrada is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We encourage candidates from all backgrounds to apply.

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Jobs at this company:

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🔥 Manager, Clinical Data Management

Posted 8 days ago

📍 United States

🔍 Biotech or pharmaceutical

🔧 Requirements

Bachelor's Degree in a Science-related or technical field or a similar area of focus and a minimum of 6 + years of experience within the biotech or pharmaceutical industry.
Experience with the full Clinical Data Management activity life cycle (start-up, maintenance, and closeout).
Established knowledge and experience working with Medidata Rave EDC.
Knowledge of MedDRA and WHODrug coding, with experience overseeing coding and SAE reconciliation activities for clinical trials.
Strong documentation and organizational skills, as well as a proven ability to be self-motivated and able to work independently.
Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders.

💡 Responsibilities

Oversee and lead data management personnel at the CRO, ensuring the deliverables are aligned with business needs and timelines.
Author, review, and revise related study plans, including Data Quality Management Plans, Data Validation Plans, Data Review Plans, eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
Represents Data Management on cross-functional project teams.
Work closely with biostatisticians and other data scientists to analyze clinical data and generate statistical reports.
Participating in the preparation of clinical study reports and other regulatory documents.
Work with the clinical team to define study data review plan specifications.
Prepare and provide data listings and reports as required (e.g. leadership reporting, DMCs, etc.).
Provide review and guidance to protocol development as it relates to data collection and management.
Lead the study team's activities regarding data management throughout the study lifecycle, from planning to start-up, conduct, and close-out.
Accountable for creating and delivering Data Management documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.) and ensure documentation is appropriately filed within the Trial Management File (TMF).
Lead or support the development of contracts with external vendors for data collection, cleaning, and reporting, and review the Scope of Work related to data management responsibilities.
Partner with internal functional teams to manage and coordinate data collection and maintenance with external vendors to ensure deliverables and project milestones are being met.

LeadershipProject ManagementSQLData AnalysisCross-functional Team LeadershipMicrosoft ExcelRESTful APIsDocumentationData modelingData management

Posted 8 days ago

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🔥 Principal Scientist, Pharmacometrics

Posted 10 days ago

📍 United States

🔍 Biopharmaceutical

🔧 Requirements

Ph.D. in pharmaceutical sciences, pharmacology, pharmacometrics, pharmacokinetics, or related discipline or Pharm.D. or M.D. with relevant experience.
4+ years’ experience with background in the application of mathematical, pharmacokinetics, and statistical methods within pharma/biotech industries or drug development.
Experience using Phoenix WinNonlin, R, NONMEM, MATLAB, or other pharmacokinetic and modeling software.
Strong mathematical model development and analytical skills.
Proficient documentation and organizational skills, as well as proven ability to be self-motivated and able to work independently.
Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders.
Ability to travel approximately 15% of the time, as determined by the needs of the business.

💡 Responsibilities

Use modeling approaches to advance clinical and translational research at Entrada Therapeutics.
Lead cross-functional teams with scientific acumen to develop and execute. pharmacometrics for programs across all phases of drug development.
Support the development of diverse modeling strategies and execution, in collaboration with the Head of Clinical Pharmacology, to bring value to the Entrada portfolio.
Work collaboratively with functional partners, including Clinical Development, Biostatistics, Non-Clinical Product Development, Clinical Operations, and Regulatory to deliver on both project team and corporate objectives.
Author regulatory documents including analysis plans, study reports, population PK reports, exposure-response analyses reports and other similar documents.
Monitor work with CROs and other external vendors to ensure compliance with agreed protocols, quality standards, and timelines.

Project ManagementData AnalysisDifferential EquationsMatlabAlgorithmsCommunication SkillsAnalytical SkillsMicrosoft OfficeDocumentation

Posted 10 days ago

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🔥 Contracts Specialist

Posted about 1 month ago

📍 United States

🧭 Full-Time

🔍 Biopharmaceutical

🔧 Requirements

B.A. / B.S. degree.
5+ years of experience in contract administration, ideally in life sciences or biotechnology.
Familiarity with contract management systems.
Strong understanding of key contract concepts and negotiation of contractual elements.
Highly organized with a strong attention to detail and accuracy.
Ability to work cross-functionally and address business needs.
Critical thinking skills to devise creative solutions.
Ability to prioritize tasks and remain agile in a fast-paced environment.
Commitment to continuous improvement and efficiency.
Desire to learn and grow within the role.

💡 Responsibilities

Support the end-to-end contract process for initiation and renewal, including communication with stakeholders, drafting agreements, and maintaining records.
Contribute to the development, updating, and maintenance of contract templates and procedures.
Manage outside counsel invoices and liaise with the Legal Department for review.
Oversee and assist in the review and negotiation of various agreements.
Act as a subject matter expert on contracting, finance requirements, and contract lifecycle management.
Ensure compliance with contract terms and liaise with the Finance department.
Participate in key functional team meetings to align contractual workstreams with business priorities.

NegotiationAttention to detailOrganizational skillsComplianceCritical thinkingCross-functional collaboration

Posted about 1 month ago

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🔥 Senior Clinical Trial Manager

Posted 2 months ago

📍 United States

🔍 Biopharmaceutical

🔧 Requirements

BA/BS degree with 7+ years of experience supporting and independently managing clinical trial activities.
Strong knowledge of ICH/GCP and regulatory requirements.
Strong experience in the drug development process including trial design and management.
Excellent verbal and written communication skills.
Proven ability to work effectively across functions.
Ability to travel approximately 20% of the time.

💡 Responsibilities

Ownership of all operational aspects of clinical trials, including CRO and vendor management.
Lead and/or support study activities, including vendor evaluation and selection, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs.
Proactively identify and support resolution/escalation of trial conduct-related issues.
Manage and lead cross-functional trial teams, including collaborating with internal team members and external vendors for the planning and execution of clinical trials, through closeout.
Provide regular up-to-date trial information and updates on trial progress/performance to internal stakeholders.
Oversee clinical monitoring from site qualification to closure visits to assure data integrity.
Oversee the review/cleaning and reconciliation of all clinical data to support timely database lock.
Partner with stakeholders to develop and implement study-specific training to relevant personnel.
Support development of department documentation, such as SOPs.
Help develop and maintain study budgets.

Project ManagementData AnalysisCross-functional Team LeadershipBudget management

Posted 2 months ago

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