Clinical Scientist (CONSULTANT)

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 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., 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