Scientist II, Toxicology

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, 50 and 51 skipping amenable. Entrada has 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.

The Perfect Addition to Our Team

You are a highly motivated and dependable Scientist II who thrives in a collaborative and fast-paced environment. You are well organized and like to share best practices in toxicology that you’ve gained over the years to guide the team on detailed studies. You have a team player mentality and excellent communication skills that will allow you to collaborate effectively as you work alongside your team, as well as cross-functionally within the organization.

The Opportunity

The Scientist II will report to the Director, Toxicology, and serve as a key toxicology liaison and subject matter expert, supporting both internal discovery efforts and external contract research organization (CRO) activities. The ideal candidate will provide scientific and strategic input for supported programs and ensure that drug discovery and toxicology studies are conducted in accordance with protocols and are aligned with the overall development strategy.

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.

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:

• 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). Diplomate of the American Board of Toxicology (DABT) is a plus.
• 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.
• This is a US based remote position with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. #LI-Remote #LI-JF1

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.

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