Job Description

Join to apply for the Clinical Compliance Consultant role at BioSpace 1 day ago Be among the first 25 applicants Join to apply for the Clinical Compliance Consultant role at BioSpace Get AI-powered advice on this job and more exclusive features. 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. Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. 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 a seasoned leader in the pharmaceutical industry who is eager to shape and implement business operations strategies for clinical compliance. You are well organized and collaborative, able to work seamlessly with teams to drive clinical initiatives. You thrive in a fast-paced environment, juggling priorities, and stepping in wherever needed. Your strong interpersonal skills enable you to build effective relationships inside and outside the company. Part-time, expected 10-20hours/week The Opportunity The Clinical Compliance Consultant is responsible for supporting GCP Compliance infrastructure build and maintenance, including Clinical SOP development, storyboard development for inspection readiness, and acting as a Compliance SME for the clinical study teams. This role will support cross-functional study teams to ensure that actions, systems, and processes are compliant with GCP to meet ongoing portfolio demands Responsibilities Lead the development and implementation of GCP Excellence in Clinical Trials strategies to enable clinical trial functional areas and study teams to embed inspection readiness and process adherence into ways of working. Collaborate with study execution team leadership on adherence to clinical trial delivery procedures and development of effective mitigation and escalation strategies for inspection readiness issues or risks, and ensure effective flow of information between internal and external stakeholders. Proactively identify and lead assessments for process/therapeutic area/project risks and drive prioritization of quality deliverables for audits and inspections. Identify and implement areas for process optimization and delivery tools to promote study team preparedness for end-to-end clinical trial delivery compliance. Partner with Quality Assurance to ensure end-to-end clinical trial delivery compliance and an aligned approach to inspection readiness strategy. Ensure risk-based TMF oversight strategies for study execution teams. Monitor compliance of TMF processes and oversight of resources in the execution of inspection readiness plans. Serve as subject matter expert, supporting business process ownership for Inspection Readiness and TMF. Contributes to and may lead defined GCP Excellence in Clinical Trials initiatives and departmental goals and objectives. 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: Bachelor’s or Master’s degree in life sciences with 10+ years of experience in clinical drug development, including direct inspection and inspection-readiness experience across R&D disciplines (minimally clinical operations, biostatistics, and data management). Expertise in global clinical trial execution and knowledge of key clinical systems (CTMS, IRT, eTMF, EDC). Strong understanding of ICH-GCP guidelines and vendor management. Experience in leading projects and coordinating collaboration with cross-functional teams. Strong strategic thinking, planning, execution, and communication skills. Global/international experience required, including ability to collaborate with colleagues and staff in other locations. Excellent communication, leadership, and organizational skills. This is a US based remote position with a strong preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. Ability and willingness to travel 10% (domestic/international) is required. The Perks By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer. 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. Privacy Statement Entrada Therapeutics, Inc. (the “ Entrada ,” “ we, ” “ us, ” or “ our ”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used. 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