Entrada Therapeutics

👥 101-250💰 $100,000,000 Post-IPO Equity 9 months agoBiotechnology Emergency Medicine Medical Health Care Genetics💼 Private Company

Website LinkedIn Email

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.

Related companies:

🏢 BetterHelp

👥 101-250 Internet Mental Health Therapeutics Wellness Health Care Health Diagnostics

Website LinkedIn Email Facebook Twitter

🏢 Reveleer

👥 101-250💰 $65,000,000 Debt Financing about 1 year agoArtificial Intelligence (AI)SaaS Machine Learning Information Technology Health Care

Website LinkedIn Email Facebook Twitter

🏢 BioRender

👥 101-250💰 $15,319,133 Series A almost 2 years agoLife Science Graphic Design Software

Website LinkedIn Email Facebook Twitter

Jobs at this company:

Apply

🔥 Clinical Trial Manager (CONTRACT)

Posted 26 days ago

📍 United States

🧭 Contract

🔍 Biopharmaceutical

🔧 Requirements

BA/BS degree with 7 + years of combined 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, trial planning and management, and CRO and vendor oversight.
Excellent verbal and written communication skills.
Proven ability to work effectively across functions.
Expected travel up to 20%.

💡 Responsibilities

Lead and/or support unblinded and blinded 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 regular updates on trial progress/performance to internal stakeholders.
Oversee clinical monitoring from site qualification to site closure visits to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records.
Oversee the review/cleaning and reconciliation of clinical data, including EDC, PROs, and 3rd party labs to support timely database lock and the accurate analysis of clinical data.
Partner with relevant stakeholders to develop and implement appropriate study-specific training to all relevant study-related personnel (internal, CRO, Site staff, and other relevant 3rd parties).
Support monitoring activities and visit clinical study sites as needed.

Project ManagementData AnalysisGCPCross-functional Team LeadershipCommunication SkillsCollaborationProblem SolvingRisk ManagementStakeholder managementData management

Posted 26 days ago

Apply

🔥 Scientist II, Toxicology

Posted 29 days ago

📍 United States

🔍 Biopharmaceutical

🔧 Requirements

Ph.D. (or equivalent) degree in Toxicology, Pharmacology, or a related discipline with 2 + years or a MS and 6 + years in the biopharmaceutical industry, including experience with toxicology testing across multiple modalities (ie, oligonucleotides, biologics, small molecules).
Current or previous study director experience, with expertise in providing toxicology support on cross-functional development and discovery teams throughout various stages of development
Strong knowledge of GLP regulations.
Knowledge of biochemical and mechanistic toxicology, and ability to design and interpret studies exploring mechanisms of toxicology involving biochemical, functional, and/or structural endpoints.
Knowledge of human risk assessment, as it pertains to drug development.
Strong scientific and leadership skills, with effective written and oral communication abilities, particularly in crafting clear and accurate documents for global regulatory submissions and health authority responses.
Ability to effectively communicate and interact with co-workers at all levels and to work independently and on teams.
Strong understanding of ICH, FDA and EMA guidance related to nonclinical assessment of drug candidates.

💡 Responsibilities

Serve as Study Monitor for non-GLP and GLP studies conducted at CROs while ensuring compliance with Good Laboratory Practice (GLP) regulations and all company/department Standard Operating Procedures (SOPs).
Communicate toxicology study findings to Toxicology management and program teams in a timely manner.
Ensure internal and external studies are conducted in strict accordance with protocols and aligned with overall program timelines.
Contribute to the design and implementation of the toxicology strategy for programs in various stages of development.
Actively participate in the critical review of submission documents such as CTDs for INDs and NDAs, Investigator Brochures, PIPs, briefing books, etc. to support clinical trials and drug registration.
Serve as Toxicology subject matter expert for multidisciplinary investigative efforts to address/resolve program-related toxicology issues/concerns.
Review and edit toxicology study protocols and reports with regard to scientific design, interpretation and regulatory compliance (GLP, animal welfare and safety).
Provide scientific collaboration within the Product Development team and across discovery groups to help evaluate and nominate drug candidates with minimal or predictable toxicity profiles.
Actively participate in Product Development scientific discussions for compounds across the portfolio.
Evaluate and apply new scientific methodologies in order to maintain scientific excellence, increase productivity, meet our research and drug registration needs, and minimize or resolve toxicity-based issues.
Dedication to an atmosphere of scientific excellence, open communication, and creativity to help achieve company and departmental goals.

Data AnalysisProduct DevelopmentCommunication SkillsAnalytical SkillsCollaborationWritten communicationMS OfficeResearch

Posted 29 days ago

Apply

🔥 Manager, Clinical Data Management

Posted about 2 months 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 about 2 months ago

Apply

🔥 Principal Scientist, Pharmacometrics

Posted about 2 months 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 about 2 months ago

Apply

🔥 GLP Quality Assurance Lead (CONTRACT)

Posted about 2 months ago

📍 United States

🧭 Contract

🔍 Biopharmaceutical

🔧 Requirements

A BS/BA with 7 + years of relevant pharmaceutical or biotechnology experience, with 4 + years working directly in GLP Quality Assurance.
Strong knowledge of GLP/GCP regulations.
Demonstrated ability to function in a fit-for-purpose environment.
A risk-based mindset with previous experience operating in small company environments.
Excellent verbal and written communication skills.
The ability to work effectively across functions.
Desire to work in an innovative, fast-paced, and collaborative team and company.
Ability to travel approximately 15% of the time, as determined by the needs of the business.

💡 Responsibilities

Build a fit-for-purpose Quality Management infrastructure for internal laboratory operations in collaboration with Discovery, Product Development, Pharmacology, and Toxicology teams.
Provide quality oversight of GLP and GCLP partners by attending vendor meetings, leading implementation of the appropriate procedures for Sponsor oversight, and supporting or leading the review and approval of the documentation.
Provide in-house expertise and support for non-GxP lab teams to assure data integrity of internally generated laboratory data used in regulatory authority interactions and submissions.
Review SOPs, data, and reports, as needed.
Lead Quality Event activities such as investigation, root cause analyses, and CAPA development and ensure appropriate documentation.
Collaborate and educate cross-functionally to ensure successful implementation of new processes and procedures.
Partner with Quality Vendor Management to support audit activities.

Communication SkillsCollaborationComplianceQuality AssuranceRisk Management

Posted about 2 months ago

Apply