Become an Entradan

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We exist to help patients and their families live better lives.

Our Values

We love science and our values bind us together to create an environment that is as unique as our research. We are building a company culture where everyone can belong, contribute and grow. Join us.

We connect to and are inspired by our mission to drive innovation and unlock our full potential. We strive for this every day and in every role, so that each Entradan can grow and fully contribute to our community.

Entrada takes care of you so you can focus on our science and mission; our perks and benefits are designed to meet your needs regardless of what season of life you are in. We celebrate the big and the small and rally around our collective ability to make a difference in the lives of patients and their families.

Humanity

We genuinely care about patients and about one another.
Tenacity

We're relentless and persistent in the pursuit of developing therapies for patients.
Creativity

We're creative problem solvers.
Collaboration

We're more than the sum of our parts.
Curiosity

We've got a growth mindset.

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Listen as Dipal Doshi, our CEO, shares more about our mission, the culture we’re building and how we’re working together to develop new therapies to treat devastating diseases.

Meet Our Entradans

BK Choi, PhD

Senior Principal Scientist, Product Development
Murali Mallem

VP and Head of CMC
Kimberli Kamer, PhD

Senior Scientist II, Pharmacology
Nanjun Liu

Director, Bioanalytical Lead
Nick Long, PhD

Senior Scientist II, Antibody and Protein Engineering
Sara Blake

Senior Research Associate, Neuromuscular and Cardiac Biology
Nelsa Estrella, PhD

Director, Neuromuscular Therapeutics
Leo Qian, PhD

Co-founder & VP, Discovery Research

What Sets Us Apart:

Since our inception, we have worked to build a high-performing, inclusive and diverse team, which is a core element of our culture. Entradans are committed to making a difference in the lives of patients, their families and care partners. We believe that by embracing differences, we have a unique advantage in challenging the status quo to apply innovative thinking to long-existing medical challenges.

56% Identify as women
52% Asian, Hispanic, Latino, Black, or African American
62% Of our Senior Leadership Team and Board is made up of women and minorities

Self-reported, as of March 2024.

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Our Comprehensive Benefits:

Wellness

We offer a $500 wellness benefit to support you and your individual priorities.
Fuel

Subsidized lunches, snacks, cold brew, drinks and treats.
Commuter Benefits

We offer $300 to cover your commute, however you do it.
Connections

Organized coffee dates, company-wide activities and gatherings.
Development & Learning

We offer individual and broad approaches to growth.
Mobile Stipend

We help you stay connected by offsetting your data plan.
Swag

We always offer opportunities to show your love for Entrada.
Parental Leave

We give you time to connect and bond with your new child.
Milestones

Personal or professional, we celebrate the big and small stuff.

Excited by what you see? Check out our Current Openings and Benefits and apply to join the Entrada team!

Learn About Our Benefits

Current Openings

Check out our current openings below.

Vice President, Clinical Development

Boston, MA

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Associate Director, Clinical Data Management

Boston, MA

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Scientist, Biologics (CONTRACT)

Boston, MA

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Scientist I, Downstream CMC

Boston, MA

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Senior Research Associate, Formulation and Analytical Chemistry (CONTRACT)

Boston, MA

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Director, Biostatistics

Boston, MA

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Research Associate, Antisense Oligonucleotide (CONTRACT)

Boston, MA

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Senior Clinical Trial Manager

Boston, MA

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Director, Quality GCP & GLP

Boston, MA

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Senior Research Associate, Translational Sciences (in vitro)

Boston, MA

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Research Associate I, Downstream CMC (CONTRACT)

Boston, MA

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Senior Scientist II, Bioanalytical

Boston, MA

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There's more to explore

Boston, MA

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. We have also partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

Responsibilities

Provide oversight and leadership of clinical programs including strategic planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Entrada SOPs.
Support growth and management of Clinical Development function, including oversight of clinical leads, biostatistics, clinical pharmacology and biomarkers.
Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH/GCP, and Entrada SOPs.
Review clinical data from all phases of development and assist in generating study reports and publications.
Serve as study medical monitor, as needed.
Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and Principal Investigators.
Represent Entrada’s clinical team in interactions with regulatory agencies.
Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
Collaborate closely with internal research team to integrate translational research into development and clinical strategies, and regulatory submissions.
Responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports.
Organize and present at relevant clinical advisory boards, data monitor committees and medical/scientific meetings.
Travel nationally and internationally, as needed.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

MD or DO (physician) required, preferences for formal training in neuromuscular disease.
10+ years of industry experience.
Experience with clinical development in Neurology/Neuromuscular disorders.
Strong scientific background.
Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
Experience with all aspects of management of clinical trials from inception to completion across all phases of development including study design.
Experience in communicating/presenting key/complex information to department/functional lead(s)/senior management.
Strong knowledge of FDA and ICH regulations.
Expert knowledge of Good Clinical Practice (CGP).
Ability to multi-task and manage several projects in parallel, paying attention to detail.
Ability to forge cross-functional working relationships with internal teams and external project partners.
Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion.

The Perks

By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Third Party Staffing Agencies

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

Privacy Statement

Entrada Therapeutics, Inc. (the “Entrada,” “we,” “us,” or “our”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are excited about the opportunity to lead and support clinical data management and the progress of our clinical trials here at Entrada. You are well organized and understand how to navigate different types of clinical data sets. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, in order to effectively build working relationships inside and outside of the company.

The Opportunity

This individual will report into the SVP of Clinical Operations and support the clinical data management across multiple drug development programs including the development and implementation of data standards. They will be responsible for the generation of multiple data sets and systems, partnering effectively with our CRO partners to achieve project milestones and clinical study timelines in alignment with company goals and in compliance with local, ICH, GCP, and company policies and procedures.

Responsibilities

Provide expertise and contribute to the strategy and development of the Clinical Data Management Systems to ensure data quality in support of clinical study data milestones and deliverables
Oversee and lead data management personnel at the CRO, ensuring the deliverables are aligned to the business needs and timelines
Lead and support establishment of systems and processes to help ensure clinical data security and integrity
Develop and/or write the database design, edit checks, CRF completion guideline, and Data Management Plan for in-house data management activities ensuring CDASH, ADaM, and SDTM standards
Work cross functionally to standardize data collection and reporting
Standardize and manage the clinical data flow process to data delivery for analysis purposes
Lead and/or contribute to standardization and process improvement initiatives
Author, review, and revise related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
Represents DM on cross-functional project teams & submission Teams.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

BS in computer science, or a science-based subject with 8 + years of clinical data management experience in industry, with experience across various indications and EDC platforms.
Strong CRO vendor management and oversight experience
Solid technical skills across data platforms; programming experience preferred
Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
Experience in regulatory GCP inspections/audits preferred
Experience with CluePoints, Spotfire, eluminate or other data softwares
Excellent verbal and written communication skills
Desire to work in a collaborative and innovative environment

The Perks

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are highly motivated and a dependable Scientist who thrives in a collaborative and fast-paced environment. You are detail-oriented, highly versatile in strain engineering and possess strong communication skills with cross-functional stakeholders. You will be responsible for genetic modifications, genotype/phenotype characterization, recombinant protein expression/purification, documenting experiments, and coordinating timelines with internal teams.

The Opportunity

In this role, the Scientist will be responsible for targeted gene knock-in and knock-out to engineer yeast metabolic machinery. The ideal candidate will conduct endogenous gene knock-out and introduce heterologous genes for glycan engineering. The Scientist will manage the strain inventory and maintain a good experimental record in electronic lab notebooks. They are expected to interpret and present research data and findings in internal scientific meetings as well as prepare procedures and technical reports.

Responsibilities

Vector design & cloning for gene knock-in/knock-out.
Perform targeted gene knock-in/knock-out & validate its genotype in yeast.
Confirm the relevant gene phenotype using recombinant proteins.
Execute recombinant protein expression and affinity purification.
Collaboration with CMC analytics for glycan analysis.
Organize and document all experimental data and connect with all related in vitro and in vivo
Contribute to reports and presentations during internal meetings.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

PhD in Molecular Biology, Genetics, Cell Biology, or related scientific field with 1+ years of experience in industry/academic experience.
Hands-on experience in Molecular Biology skills (primer design, PCR, cPCR, qRT-PCR, various gene cloning methods, genomic DNA prep, gene sequence analysis, coli & yeast transformations etc.)
Familiar with bioinformatics databases & tools.
Design plasmid (knock-out/knock-in) constructs and genomic DNA manipulation.
Extensive experience in yeast metabolic engineering is plus.
Experience in yeast (Pichia pastoris) gene knock-out/knock-in.
Experience in yeast N-glycan modification & knowledge about N/O-glycan structures is a plus.
High-throughput screening in recombinant protein expression in Pichia pastoris.
Recombinant protein characterization (SDS-PAGE, WB, dot blot, Li-Cor).
Affinity protein purification (His-tag, Protein A/G).
Excellent communication and collaboration.
Require excellent organization skill & time management.

The Perks

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are versatile, self-motivated, and looking forward to rolling up your sleeves to contribute to the overarching goals. You enjoy a fast-paced, highly dynamic environment where you’ll learn and grow in the role. You follow up and follow through, connecting problems with solutions efficiently. You are a good communicator and enjoy collaborating with internal and external stakeholders.

The Opportunity

The Scientist I, Downstream CMC will support the company on a critical growth trajectory. Conducting high throughput screens and developing downstream chromatography, including but not limited to Affinity, HIC, IEX, SEC, and MMC. They will perform and lead these activities with minimal supervision. The ideal candidate will interact across different functional groups, including Discovery and Pharmacology. Your ability and desire to thrive in a nimble, fast-paced, results-driven environment will set you up for success.

Responsibilities

Perform high-throughput screening of different chromatography resins/columns and identify purification conditions amenable to scale-up for recombinant proteins and protein-conjugates.
Execute primary separations (homogenization, solubilization, refold), purification, and formulation.
Accountable for designing experimental plans for purifying recombinant proteins and protein conjugates.
Execute identified experimental plans independently with minimal supervision, analyze results, and communicate them effectively in group meetings.
Coordinate with Upstream, Analytical, and Biologics Discovery groups to complete downstream activities.
Develop and generate protocols, procedures, and records to support high throughput screening.
Ensure well-organized, clear, and complete records of all experimental activities in laboratory notebooks promptly.
Maintain downstream lab equipment and inventory of reagents and consumables in collaboration with other team members.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

PhD in Biochemistry, Biochemical Engineering, or related scientific field with 1+ years of experience in purification and characterization of recombinant proteins.
Experience purifying recombinant tagless and tagged proteins, including antibodies and enzymes from various hosts, e.g., E. coli, CHO, and Pichia.
Skillful in identifying & resolving purification issues or proactively optimizing purification methods. Demonstrated evidence in scientific publications/abstracts/posters is expected.
Ability to proactively prioritize and flexibly drive experimental designs.
Hands-on experience working with deep well plates (resin screening) and AKTA/NGC FPLC systems to purify recombinant proteins using affinity, HIC, MMC, IEX, and SEC chromatography.
Experience with TFF operation to concentrate and diafilter recombinant proteins.
Knowledge of biologics downstream process development strategies (including inclusion body solubilization, refolding, column chromatography, conjugation, and formulation) and familiarity with best protein purification practices.
Excellent communication skills (oral and written) and ability to work effectively across departments.
Growth mindset with the ability to adapt to highly changing priorities.
Experience in a fast-growing, dynamic organization; preferably small biotech is preferred.
Experience in handling high throughput instruments such as protein maker is preferred.

The Perks

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are a highly motivated Senior Research Associate who thrives in a collaborative and fast-paced environment. You are detail-oriented and interested in working at the intersection of our Formulation and Analytical Development teams.

The Opportunity

In this role, the Senior Research Associate will be responsible for the formulation of drug substances and the operation of multiple instruments including HPLC, LC-MS, and UV-Vis. They will formulate and characterize the formulation of oligonucleotides, peptides, conjugates, and other novel molecules. The ideal candidate will also manage the chemical inventory, ordering chemicals and supplies, and maintaining a good experimental record will be a key part of your role. The Senior Research Associate will interpret and present research data and findings in internal scientific meetings as well as prepare procedures and technical reports.

Responsibilities

• Lead oligonucleotide/peptide/conjugates formulation for in vitro and in vivo studies to support all discovery projects.
• Analyze formulation samples using various instruments such as LCMS and HPLC.
• Coordinate with neuromuscular and discovery biology teams for data and sample transfers.
• Organize and document all experimental data and connect with all related in vitro and in vivo.
• Contribute to reports and presentations. During internal and external meetings, you should be ready to interpret and present research data and findings.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

BS (4+ years relevant experience) or MS degree (2+ years relevant experience) in Pharmaceutical Sciences, Chemistry, Biology, Bioengineering, or a related field.
Hands-on experience of oligonucleotide/peptide/conjugates formulation for in vitro and in vivo biological assays is required.
Ability to execute pipetting tasks accurately and efficiently to maintain the integrity of experimental results.
Hands-on experience with analytical instrumentation such as UV-Vis, IEX-HPLC, RP-HPLC, LCMS for formulation characterization is required.
An understanding of laboratory safety and best practice is required.
Experience with aseptic handling techniques is preferred.
Attention to detail and the ability to thoroughly document experimental work in electronic lab notebooks (ELNs).
Understanding of oligonucleotide/peptide chemistry as well as the knowledge of analytical chemistry is a plus.
Excellent written skills to author SOPs and technical reports, and verbal communication skills to present internally and externally.
To be effective on our team, you must have the ability to interact effectively in a multi-disciplinary, fast-paced research environment as well as the ability to multi‐task to meet research and development goals.

The Perks

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are excited about the opportunity to lead biostatistics and support the progress of our clinical trials here at Entrada. You are well organized and will be able to independently provide strategic statistical input to drug development planning. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You drive for results, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, to effectively build working relationships inside and outside of the company.

The Opportunity

Reporting to the SVP, this individual will guide day-to-day statistical operations and the development of statistical methodologies. You will work with internal and external stakeholders to support and oversee a portfolio of clinical studies. The individual will support the strategic growth of the biostatistics function at Entrada.

Responsibilities

Responsible for leading statistical strategy for assigned drug programs, including input to clinical development plans, clinical study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications
Accountable for oversight of the production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) as performed by internal and/or external resources
Serve as a key leader in the clinical product team, providing statistical strategy and inputs in protocols, data monitoring committee (DMC) charters, clinical study reports (CSR) and other study-level documents
Serve as the biostatistical lead to support the team to design and support data collection, analyses, interpretation of efficacy, safety, and biomarker results
Author/review the statistical analysis plan for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listings
Define/review the randomization procedures and oversight of the production of randomization lists
Review study Case Report Forms, data management plan and other data management related documentation to ensure that specific statistical requirements defined in the study protocol are met
Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery
Support and participate in the development of department strategies and cross functional initiatives on standards, infrastructure and processes

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

PhD with 10 + years or MS and 12 + years of relevant statistical analysis roles in the biotech/pharmaceutical industry is required
Experience with a broad array of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs in rare disease trials
Demonstrated track record in various disease indications, endpoints and appropriate statistical/regulatory requirements
Experience in supporting responses and submissions to health authorities (FDA, EMA)
Strong vendor management and oversight experience
Proficiency in statistical analysis software (SAS and R) and sample size calculation software (e.g. EAST and/or NQuery)
Excellent verbal and written communication skills
Ability to travel up to 10%.

Preferred Skills:

Direct line people management
Deep understanding of Biomarkers, PK/PD, PRO and RWE
Neuromuscular drug development experience #LI-Remote LI-JF1

The Perks

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Boston, MA

The Organization

The Perfect Addition to Our Team

You should be versatile, self-motivated, and looking forward to rolling up your sleeves, as you’ll be involved in all aspects of oligonucleotides. You will be supporting efforts for antisense oligonucleotides, small interfering ribonucleic acids and gene editing platforms. You should be ready to support our team of drug discovery scientists as we design, prepare and characterize oligonucleotide constructs and carry out analytical assays for functional validation both in vitro and in vivo.

The Opportunity

In this role, the Research Associate will have the opportunity to be involved in a lot of different aspects of our oligonucleotide work; for example, processing and analyzing samples from in vitro and in vivo studies will be one of your areas of work. They will be expected to work through techniques like RNA/protein extraction, RT-PCR, RT-qPCR, ELISA, and Western Blot. You’ll also have the opportunity to maintain and culture cell lines for in vitro studies, as well as developing and executing cell-based assays for validating biological activity of oligonucleotide therapeutics. Lastly, the Research Associate will have the opportunity to prepare SOPs and other reports and publications.

Responsibilities

• Maintain and culture primary and secondary cell lines for in vitro studies.
• Develop and execute cell-based assays for validating biological activity of oligonucleotide therapeutics.
• Use techniques like RNA/protein extraction, RT-PCR, RT-qPCR, ELISA, and Western Blot to process and analyze samples from in vitro and in vivo studies.
• Produce high quality data that will contribute to new therapeutic development.
• Contribute to reports and presentations. During internal and external meetings, you should be ready to interpret and present research data and findings.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

BS/MS in molecular biology, pharmacology, biochemistry or similar field. At least 2+ years’ experience in a lab or industry experience.
Hands-on biochemistry experience with techniques like RT-PCR, qPCR, ELISA, fluorescence microscopy, cell culture and western blotting and other protein assays.
Hands-on experience with oligonucleotides is a plus.
To be effective on our team, we need you to bring excellent working knowledge and familiarity with graphic software and Microsoft Office.
You should be collaborative and a strong communicator and can multi-task effectively.

The Perks

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are excited about the opportunity to spearhead clinical trial activities and support the build of our clinical operation function here at Entrada. You are well organized and like to share best practices in clinical operations. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, in order to effectively build working relationships inside and outside of the company.

The Opportunity

This individual will lead in the day-to-day operations, planning, set-up, execution, and closeout of assigned clinical trials. They will oversee the planning and management of the operational aspects, including CRO and vendor oversight, to achieve project milestones and clinical study timelines in alignment with company goals and in compliance with local, ICH, GCP, and company policies and procedures.

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 regular updates on trial progress/performance to internal stakeholders (enrollment, eligibility, protocol deviations, AE reporting etc.).
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 all clinical data, including EDC, PROs, and 3^rd 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 3^rd parties).
Support development of department documentation, such as SOPs.
Help develop, organize, and maintain study budgets, working with business operations to ensure accurate forecasting.
Support monitoring activities and visit clinical study sites as needed.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

BA/BS degree with 8 + years direct experience supporting and independently managing clinical trial activities.
Strong knowledge of ICH/GCP and regulatory requirements.
Deep 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%.#LI-Remote LI-JF1

The Perks

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are driven and enthusiastic. You thrive in a fast-paced collaborative environment and can manage multiple projects concurrently. You are detail-oriented and able to review and analyze quality issues quickly in order to provide robust and timely solutions.

You are dependable and accountable for your work. You are able to lead teams and develop strategies while not being afraid to roll up your sleeves and review clinical trial-specific documents and GLP reports.

You are an excellent team player and relationship builder. You know when to step in and lead something and when to offer your support. You excel at building relationships and trust with your key stakeholders.

The Opportunity

Entrada is seeking a Director, GCP/GLP Quality to manage GCP and GLP quality assurance activities. This role will ensure quality and compliance of Entrada’s development programs with respect to clinical and nonclinical studies. This position reports into the Vice President of QA.

Responsibilities

Act as GCP subject matter expert within the QA function to enhance the Quality System in accordance with ICH Guideline E6 (R2) Good Clinical Practice (GCPs), 21 CFR part 58 Good Laboratory Practices (GLP), and other global regulatory authority requirements and industry practices.
Identify controlled document improvements, creation, and training needs.
Collaborate and provide QA expertise on investigations, corrective and preventive action (CAPA) plans, trial protocol deviations, complaints, risk management, risk assessments, recalls, safety events/reporting, relevant regulatory submission sections, and trial documentation review.
Represent QA on clinical study teams and conduct QA review of clinical study protocols, study plans and protocol deviations.
Design and execute risk-based audit plans/schedules in collaboration with clinical and nonclinical study teams, including establishment of appropriate quality compliance criteria to assure compliance with regulations, guidelines, and standards.
Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts.
Conduct internal audits to assess effectiveness of Entrada’s GCP/GLP QMS and process compliance including Clinical Study Report (CSR).
Timely issuance of audit plans, reports, observations, and oversee audit response processes to drive audits to closure.
Evaluate audit observation trends and compliance risks and escalate to QA Management, as required.
Ensure the clinical and nonclinical sites are audit ready and compliant at all times.
Participate (eg, host/co-host inspections, lead or support inspection back-room/preparation room activities) during external and regulatory agency inspections.
Develop and report on key quality metrics, periodic quality reports, and audits as needed.
Ensure timely collaboration with Entrada staff to ensure any non-compliance is elevated appropriately and addressed in a timely manner.
Work cross-functionally to solve problems and produce solutions that work for the broader team.
Work across all levels in the organization to deliver GCP/GLP Quality compliance.
Partner with external collaborators, contractors, and contract research organizations to fully support drug development activities.
Lead continuous improvement initiatives.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

Scientific degree required; advanced degree preferred with 10+ years of relevant GCP experience in the biotechnology industry.
Prior regulatory inspection experience required (eg, hosting inspections, inspection readiness planning and execution, etc.)
Strong knowledge of GCP, GCLP, GLP, GVP, and ICH clinical requirements.
Prior experience with clinical and nonclinical studies and CRO oversight.
Experience working on US and international phase 1 and 2 clinical studies.
Real-time working knowledge of Quality Assurance methodologies.
Strong organizational skills and ability to work independently.
Strong verbal and written communication skills.
Strong ability to create practical and efficient processes.
Ability to travel 20% of the time, as dictated by the schedules of mandatory events and medical meetings. #LI-Remote #LI-JF1

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are self-motivated, highly collaborative, and eager to roll up your sleeves, as you will contribute to several aspects of our translational biology group. Your background should be in biology or biomedical engineering, with experience in cell biology, in vitro 2D and 3D disease models, and molecular biology. You will work alongside team members to help characterize and validate innovative medicines to treat some of the most challenging diseases.

The Opportunity

The Senior Research Associate will have the opportunity to work with disease models and cell-based assays, such as ddPCR, ELISA, LabChip, and confocal microscopy. They will support pre-IND and IND-enabling studies using in vitro cell systems. The ideal candidate will be managing and ordering chemicals and supplies, as well as preparing procedures and other reports. There will also be opportunities to present data and research findings at internal meetings.

Responsibilities

Maintain and culture the in vitro 2D and 3D cell models to support the in vitro preclinical studies.
Conduct experiments to critically assess in vitro assays (e.g. DNA/RNA/protein extraction, RT-PCR, RT-qPCR, ddPCR, western blot, ELISA, immunostaining, imaging, etc.) and data analysis.
Collaborate with Neuromuscular, Ocular, and Biologics groups for method transfer and to acquire materials for subsequent cell-based assay development and testing.
Ensure reagents for in vitro assay experiments are well stocked and keep a detailed record of all experiments in a digital lab notebook.
Present updates regularly in the translational group meetings.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

BS in biology, biomedical engineering, or a related field with 4+ years of industry experience (or a MS in related field with 2+ years’ experience).
Strong communication and organizational skills.
Hands-on experience with in vitro assays including PCR, ddPCR, qPCR, Western blotting, and immunostaining.
Hands-on experience with muscle cells, organoid systems, and/or engineered tissues is a plus.
The ability to critically assess experimental results, troubleshoot, and come up with creative and effective solutions.
The drive to have a more complete understanding of project goals to effectively manage your time and prioritize experiments.

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Boston, MA

The Organization

The Perfect Addition to Our Team

You are a versatile, self-motivated professional who enjoys rolling your sleeves to contribute to the overarching goals. You enjoy a fast-paced, highly dynamic environment where you learn and grow in the role. You follow up and follow through, connecting problems with solutions efficiently. You are a good communicator and enjoy collaborating with internal and external stakeholders.

The Opportunity

The Research Associate I, Downstream CMC (Contract) position will support the Company’s intracellular biologics discovery programs. They will work closely with downstream and upstream teams to progress discovery and development programs. The successful candidate will execute the purification of recombinant proteins using AKTA Avant, Protein Maker and Bio-Rad NGC systems. By the end of the contract, the candidate will gain hands-on laboratory experience and a solid practical understanding of downstream operations involved in producing recombinant proteins.

Responsibilities

Prepare buffers for downstream (homogenization, solubilization, and protein purification) operations.
Operate AKTA Avant, Bio-Rad NGC, purifier, and TFF systems for protein purification.
Execute homogenization, solubilization, and refolding of inclusion bodies.
Clean-in-place AKTA and Bio-Rad systems after use.
Run SDS-PAGE gels, western blots, and endotoxin assays.
Input experimental details and observations in the laboratory notebooks.
Present data and research findings in internal team meetings.
Strong communication skills (oral and written) and ability to work effectively across functions.
Maintain inventory of reagents and consumables (as needed).
Prepare media and feed for shake flasks and fermenters (as needed).
Set up, inoculate, and operate shake flasks and lab-scale fermenters (as needed).
Sample shake flask and fermenter to monitor culture growth, metabolite levels, and protein production (as needed).
Run activity, SEC-HPLC and Ion exchange HPLC assays (as needed).

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

BS or MS degree in biochemistry, biochemical engineering, biotechnology, or a related field with prior experience in R&D laboratory.
Experience with AKTA or Bio-Rad systems for purification of recombinant proteins using multimodal chromatography, Ion exchange, and other types of chromatography.
Experience with TFF operation to concentrate and diafilter recombinant proteins (a plus).
Experience in a fast-growing, dynamic organization; preferably small biotech is preferred.
Experience in handling high throughput instruments such as protein maker is preferred.
Knowledge and use of molecular biology and protein biochemistry techniques.
Able to work outside of regular business hours and weekends.
Growth mindset with ability to adapt to changing priorities.
Strong communication skills (oral and written) and ability to work effectively across functions.
Desire to work in an innovative and collaborative environment pursuing high-reward science.

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Boston, MA

The Organization

The Perfect Addition to Our Team

As a member of the Bioanalytical group in the Product Development Team, you are versatile, self-motivated, timeline- and process-oriented, and look forward to rolling up your sleeves and diving into details, and overcoming obstacles. You will be responsible for mentoring members of the team and be accountable for their day-to-day operations and personal career development. You will successfully lead and coordinate bioanalytical support functions across various modalities, including oligonucleotide and biologics modalities, to perform both qualitative and quantitative bioanalysis in complex biological matrices. To accomplish these aims you will actively explore, investigate, and implement innovative technologies to meet program timelines. You will lead internal efforts to provide timely bioanalytical support for discovery projects and pre-IND clinical candidate studies. Additionally, you will be a key contributor to documents supporting regulatory filings and will have the opportunity to contribute to scientific publications.

You also enjoy a fast-paced environment and juggling competing priorities. You have excellent verbal and written communication skills, you follow up and follow through, bringing solutions to problems efficiently. You work successfully in a team environment with strong interpersonal skills to effectively build working relationships inside and outside the company.

The Opportunity

Work within the Bioanalytical Team to enable the full spectrum of EEV-conjugated modalities development from early discovery candidate selection through late-stage process development.

Responsibilities

Develop, qualify, and implement bioanalytical assays using LC-MS/MS and ligand binding assay (LBA) to support PK and biodistribution studies for therapeutic candidates including oligonucleotides, biologics, and peptides.
Perform both qualitative and quantitative bioanalysis in various biological matrices (plasma, CSF, urine, and tissues, etc.) across different species. Generate high-quality data and reports in a timely manner to meet project deliverables.
Oversee bioanalytical deliverables supporting discovery project activities, candidate enabling studies, and clinical candidate IND enabling studies; provide scientific guidance and technical support on method development, qualification, and sample analysis in-house as well as at CROs.
Support the implementation of new and upcoming technologies/platforms both within and outside the field of expertise to meet challenging program needs.
Mentor and train team members and colleagues on scientific concepts and technical details regarding various bioanalytical approaches.
Lead troubleshooting efforts for bioanalytical assays; Proactively identify and solve technical challenges/bottlenecks to maintain/improve assay robustness and efficiency.
Implement processes to ensure timelines are met with data integrity; communicate and interface with stakeholders including discovery, preclinical, CMC, and external CROs to define and deliver strategies in a flexible manner to support project timelines across multiple programs.
Interpret and present bioanalytical data internally as well as in cross-functional team meetings; serve as an SME on behalf of the bioanalytical team for technical, strategic, and prioritization discussions to advance program objectives.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

A PhD in chemistry, biochemistry, pharmacology, analytical chemistry, or a related field with at least 5 years of bioanalytical sciences; and an equivalent combination of education and experience (e.g. MS degree with at least 8 years experience) will be considered.
Demonstrated leadership acumen and strong project management/organizational skills; Proven track record of fostering a collaborative work environment.
Subject matter expert with extensive hands-on experience with developing, qualifying, implementing, and troubleshooting LC-MS/MS and ligand binding-based assays to support a variety of therapeutic modalities including oligonucleotides, biologics, and peptides.
Ability to work independently in a fast-paced, competing priority environment, as well as in a cross-collaborative team setting. Excellent communication skills (oral and written) and a track record of cross-disciplinary collaboration are essential.
Knowledge/experience of pharmacokinetics, drug metabolism, immunogenicity, and biomarker studies are highly desirable.
Experience with ligand binding assays such as ELISA and MSD is preferred.
Knowledge and experience with assay development, transfer, qualification, and validation to external CROs in a GLP/GxP environment is considered a plus.

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