Clinical Scientist (CONSULTANT)

The role

This individual will provide strategic and hands-on support in designing, developing, and implementing strategies to support clinical trials in Duchenne muscular dystrophy. They will spearhead data review and partner on innovative processes for clinical development phases.

What you will do

• Support interpretation of clinical data to generate summaries and insights for regulatory filings, publications, and scientific communications.
• Collaborate cross-functionally with Medical Directors, Clinical Operations, Data Management, Biostatistics, and Business Operations.
• Lead or support the authoring of selected sections of clinical study reports in partnership with Medical Directors.
• Support real-time data review and identify trends in safety and efficacy data.
• Assess protocol compliance and conduct protocol deviation reviews.
• Identify scientific and clinical quality issues to discuss with PI and study sites.
• Consult on the design of study-specific case report forms and author CRF completion guidelines.
• Perform safety and efficacy reviews in preparation for DMC.
• Lead development of department clinical data technology access, retention, and visualization strategy.
• Support innovation and strategy for the integration of new tools and technologies into phase 1-3 clinical studies.

Required qualifications

• Ph.D., PharmD, MD, Nursing, or Clinical Master’s degree in a scientifically relevant field
• 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
• Strong understanding of GCP/ICH guidelines and regulatory expectations
• Skilled in Microsoft suite as well as innovative data review 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

Nice to have

• Experience in rare disease and/or neuromuscular disease is strongly preferred
• Preference given to local New England based candidates

About the company

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. The company is advancing a development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases.