Study Start Up Lead Contractor

Entrada Therapeutics•Boston, MA

1d•Remote

About The Position

Entrada Therapeutics 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.

Requirements

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.

Nice To Haves

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.

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)