Clinical Scientist (CONSULTANT)

Entrada Therapeutics, Inc.

Boston (MA)

A distancia

USD 120.000 - 180.000

Jornada completa

Hace 4 días
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Descripción de la vacante

Entrada Therapeutics is seeking a highly motivated clinical researcher to lead and support data review across all phases of Duchenne and rare disease programs, leveraging Entrada’s EEV technology. The role emphasizes designing strategies for clinical trials, data interpretation, and cross-functional collaboration with Medical Directors, Data Management, and Biostatistics.

The candidate should have a strong background in GCP/ICH and a track record of delivering high-quality study reports, safety,

Formación

  • Ph.D., PharmD, MD, Nursing, or Clinical Master’s degree in a scientifically relevant field with 6+ years clinical development experience.
  • Proven understanding of clinical development processes for phase 1-3 studies.
  • Experience identifying trends and setting risk mitigation strategies with Medical teams.
  • Strong knowledge of GCP/ICH guidelines and regulatory expectations.

Responsabilidades

  • Support interpretation of clinical data to generate high quality summaries for regulatory filings, publications, and scientific communications.
  • Collaborate cross-functionally with Medical Directors, Clinical Operations, Data Management, Biostatistics, and Business Operations to drive execution across clinical phases.
  • Lead or support authoring of selected sections of clinical study reports in partnership with Medical Directors.
  • Perform safety and efficacy reviews to prepare for DMC, analyzing trends within programs.

Conocimientos

Clinical data review
Data analysis
Data visualization
Regulatory filings
Cross-functional collaboration
GCP/ICH knowledge

Educación

Ph.D., PharmD, MD, Nursing, or Clinical Master’s degree

Herramientas

Microsoft Excel
CRF design tools
Data review tools

Descripción del empleo

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 data review and partner on innovative processes to set the company up for success through subsequent phases of clinical development. You have a strategic mindset but have no problem rolling up your sleeves to implement the work that needs to get done. You are a self-starter and an effective communicator. You take accountability for known project responsibilities, but you can also easily adapt and accommodate the unexpected. You thrive in a fast paced, highly collaborative, flexible working environment.

The Opportunity

This individual will be highly motivated and experienced clinical researcher interested in working on all phases of clinical development. Reporting to the Executive Director, Clinical Development, this individual will provide both a strategic lens and hands on support in designing, developing and implementing strategies to support clinical trials in Duchenne muscular dystrophy, utilizing Entrada’s unique EEV technology.

The right candidate will bring scientific rigor, deep expertise in clinical data review, and a passion for improving quality of life for patients and families impacted by rare neuromuscular disorders.

Responsibilities
  • Support interpretation of clinical data to generate high quality summaries and insights to support regulatory filings, publications and scientific communications.
  • Collaborate cross-functionally with Medical Directors, Clinical Operations, Data Management, Biostatistics, and Business Operations to help drive execution across clinical phases.
  • In partnership with Medical Directors, lead or support the authoring of selected sections of clinical study reports.
  • Support real-time data review, identify trends in safety and efficacy data and assessing protocol compliance including protocol deviation reviews, escalating to Medical Monitor(s) where appropriate.
  • Identify scientific and/or clinical quality issues to discuss with PI and study sites, partnering with study team and GCP quality team members for escalations as needed.
  • Consultant on the design of study-specific case report form (CRF) and author study-specific sections of the CRF completion guidelines, ensuring CRFs are aligned with study requirements during user acceptance testing.
  • Perform safety and efficacy reviews in preparation for DMC, in conjunction with Medical Director and other internal stakeholders, analyzing trends within and across programs.
  • Collaborate with Business Operations and Data Management to lead development and innovation of department clinical data technology access, retention, and visualization strategy, to support trend identification across programs.
  • Support innovation and strategy for the integration of new tools and technologies into phase 1-3 clinical studies.
The Necessities

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

  • Humanity - We genuinely care about patients and about one another.
  • Tenacity - We are relentless and persistent in the pursuit of developing therapiesfor 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., PharmD, MD, Nursing, or Clinical Master’s degree in a scientifically relevant field, with 6 + years of clinical development experience within the biotechnology or pharmaceutical industry.
  • Proven understanding of clinical development processes to serve as subject matter expert for phase 1-3 clinical studies.
  • Previous experience identifying trends and setting risk mitigation strategies in partnership with Medical teams within clinical studies.
  • Demonstrated experience in the design and execution of clinical trials and a strong understanding of GCP/ICH guidelines and regulatory expectations.
  • Experience in rare disease and/or neuromuscular disease is strongly preferred.
  • Skilled in Microsoft suite as well as innovative data review tools (ie. patient profiles, report generating tools)
  • Self-motivated, demonstrated success in delivering assigned tasks according to timelines.
  • Demonstrated history of creative problem-solving and learning ability.
  • Ability to interpret complex data and communicate clearly with both scientific and non-scientific stakeholders.
  • Strong data analysis, data visualization and communication skills, with ability to write clear, accurate and concise documents, construct informative figures, and present to diverse audiences.
  • Desire to work in an innovative and collaborative, fast paced, mission driven environment, taking on new challenges with an adaptable mindset.
  • This is a US based remote, contract position with 40 hours per week expected, with preference given to local New England based candidates. This role will require a minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. #LI-Remote #LI-JF1
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.

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Entrada Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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