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    Junior Operations Specialist - Boston, MA, United States - Entrada Therapeutics Inc.

    Entrada Therapeutics Inc.
    Entrada Therapeutics Inc. Boston, MA, United States

    2 weeks ago

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    Description

    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 this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immune mediated diseases, among others.

    Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable.

    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.

    You are excited about the opportunity to build and develop the clinical operation function at Entrada.

    You are well-organized and like to share best practices in clinical operations that you've gleaned over the years to guide the clinical team.

    You also enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help, wherever it is needed.

    We are seeking a motivated Director of Clinical Operations to join and grow our evolving team here at Entrada Therapeutics.

    The Director of Clinical Operations will report into the Senior Vice President, Clinical Operations and Data Management, and oversee the strategic and tactical planning and execution of the DMD portfolio of clinical assets.

    You will be responsible for planning all activities related to global and/or regional clinical trials, from initial planning & study start-up through close out activities.

    You will be able to build out and manage a small team of clinical professionals to help support the goals of the organization.

    The ideal candidate will provide strategic direction and oversight, in partnership with the extended Clinical Development team.

    Provide leadership, line management, and professional development to a small team of clinical professionals to support the DMD & rare disease portfolio.


    • In collaboration with the Medical Director, contribute to protocol development and study design. Promote effective partnerships among internal and external stakeholders and provide day-to-day direction for the program and study team. Provide dedicated and creative recommendations on how to meet goals and handle identified risks.
    • Responsible for the oversight, performance, and management of clinical CROs, vendors, labs, and consultants involved in the day-to-day study management activities.
    • Oversight of the development of clinical program plans and study manuals and documents.
    • Responsible for managing program and study budgets, contract negotiation, payments, and forecasting study spending. Ensure trial adherence to International Conference on Harmonization (ICH) Good Clinical Practice (GCP), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
    • Communicate project status, including risk identification and escalation of ongoing issues, to senior leadership to ensure timely decision-making and overall risk mitigation.
    • Ensure quality clinical data review and data integrity for assigned clinical trial(s).
    • Participate in and respond to Quality Assurance and/or regulatory authority inspections as needed.
    • Assume a leadership role in developing Clinical Operations infrastructure, functions, standards, processes, and IT systems to optimize all aspects of clinical trial operations in compliance with global regulatory standards (e.g., SOP development, training, etc.).
    Creativity - We are creative problem solvers.

    • Collaboration - We are more than the sum of our parts.
    • Bachelor's degree in health sciences or related field, or equivalent.
    • Minimum of 12+ years of experience in clinical research with at least 8 years of experience in clinical study management, CRO, and vendor oversight.
    • Experience across Phase 1 through 3 clinical trial execution with a strong preference for regulatory filing and inspection experience, globally
    • Extensive and comprehensive knowledge of Good Clinical Practice (GCP), Federal Regulations, and International Regulations (International Harmonization Committee-ICH Regulations).
    • Ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
    • Minimum of 4 years of direct people management experience with demonstrated ability to build, coach, and develop high-performing teams, excellent delegation, and conflict resolution skills.
    • Strong computer literacy and skills.
    • Fluent in English (oral and written).
    • Moderate travel (domestic and international), up to 25% may be required.
    • Travel to headquarters in Boston; 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. 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.
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