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Study Start Up Lead Contractor

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. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy (DMD) who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered with Vertex Pharmaceuticals to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1).

2026 represents a catalyst-rich period for Entrada. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51). These programs are complemented by the ongoing clinical progress of our DM1 collaboration with Vertex (VX-670).

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 excited about the opportunity to spearhead clinical trial start up activities. You are well organized and like to share best practices in clinical operations and study start up. 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 partner with study leads on varying operational initiatives across on-going and new clinical studies for study start up and enrollment. This role will support the overall

planning and management of clinical trials, 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

  • Lead and/or support Sr. CTMs/CTMs with study start up and maintenance activities, including regulatory submissions, country and site selection, site budget management, site activation, ICF review, etc.
  • Collaborate with Sr. CTM/CTMs on developing study specific strategic start up or protocol amendment implementation plans.
  • Drive start-up activities including timely site selection and activation, EC submissions and query responses, document collection, and protocol amendment activities.
  • Reviewing country-level ICFs and related site or patient facing materials and routing for approval by required functional areas.
  • Review and approve site activation packages and regulatory documentation, ensuring complete and accurate information tracked in the appropriate databases.
  • Proactively identify and support resolution/escalation of issues impacting start up or trial execution.
  • Collaborate and communicate with the cross-functional trial team, including collaborating with internal team members and external vendors on related study start up activities.
  • Ensure that all assigned start up activities are on track and support study deliverables.
  • Partner with relevant stakeholders to develop and implement appropriate study-specific training and kick-off meetings to all relevant study-related personnel (internal, CRO, Site staff, and other relevant 3rd parties)

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 of combined experience supporting and independently managing clinical trial activities globally.
  • 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.
  • Ability to travel approximately 10% of the time, as determined by the needs of the business.

This is a part-time, long-term contract position estimated to be ~20-30 hours per week. The role is a US based remote position, with preference given to local New England based candidates. This role may require ad-hoc travel to the Entrada Therapeutics Headquarters located in Boston, MA. #LI-JF1 #LI-Remote 

Equal Opportunity Employer

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. 

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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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