Scientist I/Ii, Toxicology

The Organization

What's happening at Entrada Therapeutics? Our mission is to transform the treatment of devastating diseases and improve patients' quality of life using intracellular biologics. Leveraging our proprietary Endosomal Escape Vehicle (EEV)™ platform, we are creating and advancing a diverse pipeline of oligonucleotide, enzyme, protein, and peptide programs to efficiently target and engage underlying drivers of diseases.

Our novel approach to drug design and delivery addresses current challenges associated with both large and small molecule therapeutics and represents a fundamental advancement in the field of intracellular biologics.

We're a tight-knit team of experts and leaders in both therapeutics development and rare disease 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 Fit

We are seeking an experienced, skilled individual to fill the role of Scientist in the Product Development, Toxicology group at Entrada Therapeutics. The primary responsibility will be to function as a key toxicology liaison/subject matter expert in support of both internal discovery, as well as external contract research organization (CRO) activities. In this role, the person is expected to 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. In addition, the successful candidate will actively participate in scientific discussions within the Product Development group for all compounds across the portfolio.

Key Responsibilities

• Actively participate in Drug Discovery efforts providing toxicology input and guidance
• Review and edit toxicology study protocols and reports with regard to scientific design, interpretation and regulatory compliance (GLP, animal welfare and safety)
• Ensure internal and external studies are conducted in strict accordance with protocols
• Additional responsibilities as assigned by the Toxicology supervisor
• Ensure studies are performed in accordance within overall program timelines
• 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
• Contribute to the design and implementation of the toxicology strategy for programs in various stages of development
• Serve as Study Monitor for non-GLP and GLP studies conducted at CROs
• Demonstrate Entrada Therapeutics Core Behaviors
• Ensure compliance with Good Laboratory Practice (GLP) regulations and all company/department Standard Operating Procedures (SOPs)
• Actively participate in Product Development scientific discussions for compounds across the portfolio
• Dedication to an atmosphere of scientific excellence, open communication, and creativity to help achieve company and departmental goals
• Serve as Toxicology subject matter expert for multidisciplinary investigative efforts to address/resolve program-related toxicology issues/concerns
• Communicate toxicology study findings to Toxicology management and program teams in a timely manner
• As needed, act as a toxicology subject matter expert in the evaluations of potential in-licensing opportunities
• Actively 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
• 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

The Necessities

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

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

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

• Knowledge of biochemical and mechanistic toxicology, and ability to design and interpret studies exploring mechanisms of toxicology involving biochemical, functional, and/or structural endpoints
• Experience providing toxicology expertise on cross-functional development and discovery teams across different stages of development
• At least 2-5 years of appropriate post-degree experience or equivalent scientific background in the biopharmaceutical industry, including experience with toxicology testing across multiple modalities (ie, oligonucleotides, biologics, small molecules).
• Knowledge of human risk assessment, as it pertains to drug development.
• Effective written and oral communication skills, especially as they pertain to writing clear, and accurate documents for global regulatory submissions and health authority responses
• Strong understanding of ICH, FDA and EMA guidances related to nonclinical assessment of drug candidates
• Strong knowledge of GLP regulations
• Current or previous Study Director experience
• PhD (or equivalent) degree in Toxicology, Pharmacology, or a related discipline. Diplomate of the American Board of Toxicology (DABT) is a plus
• Ability to effectively communicate and interact with co-workers at all levels and to work independently and on teams
• Strong scientific and leadership skills

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.