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Senior Translational Development Advisor - Advanced Therapies (ATMP/SoHO)

hace 2 días

Barcelona

ph3Who are we? /h3 pMiMIAT Health has developed a patient-controlled longitudinal health record that makes disease evolution visible and enables data continuity across fragmented care settings for multidisciplinary teams managing hard-to-diagnose diseases. /p pOur work has been recognised through PRECISEU Best Practice Recognition, AstraZeneca ACCIÓN, Google for Startups for Sustainable Development and NVIDIA Inception. We are also part of COST Action CA24114, focused on blood, tissues and cells as starting materials for advanced therapies. /p pBuilding on this foundation, MiMIAT is now establishing a biotech translational RD arm focused initially on advanced therapies. We are assembling the scientific, clinical, regulatory, manufacturing and operational nucleus required to select promising research and advance an initial programme towards defined therapeutic-development milestones. The team and model are being shaped now, creating an opportunity for the right people to influence the initiative from its earliest stage. /p h3What is this role about? /h3 pWe are looking for an experienced bSenior Translational Development Advisor /b who can help determine how this thesis could work in practice and convert it into a credible first operating model. /p pThis is not a general advisory or networking role. We need someone who understands how cell, gene or tissue-based therapies progress from scientific research through preclinical development, where applicable, SoHO collection, CMC/GMP manufacturing, clinical studies and long-term patient follow-up. /p pThe advisor will help us identify where MiMIAT can create meaningful and defensible value, what capabilities and partners would be required, and which initial use case offers the strongest route towards a funded pilot or co-development programme. /p pThe intended outcome of the initial appointment is a clear blueprint showing what MiMIAT should pursue first, with whom, under which regulatory and operational conditions, and through which development milestones. /p h3What you’ll do /h3 ul liCritically assess MiMIAT’s current SoHO–ATMP thesis and identify its strongest assumptions, gaps and risks. /li liMap a representative patient-to-therapy pathway covering patient involvement, SoHO collection, processing or manufacturing, clinical administration and longitudinal follow-up. /li liHelp define MiMIAT’s precise role across the patient, biological-product and clinical-evidence pathways—including which responsibilities must remain with hospitals, SoHO establishments, clinical sponsors, laboratories and GMP manufacturers. /li liIdentify and prioritise the most credible initial use case for MiMIAT, such as patient engagement, longitudinal outcomes, clinical-outcome monitoring or patient-evidence coordination around an advanced-therapy programme. /li liDevelop selection criteria for potential therapeutic programmes, considering scientific validity, clinical relevance, regulatory feasibility, manufacturing requirements, intellectual property and commercial potential. /li liIdentify the key stakeholders required for the first programme, including academic investigators, clinical sites, SoHO establishments, CDMOs or GMP facilities, regulatory experts, patient organisations and potential pharma or licensing partners. /li liAssess which parts of MiMIAT’s current platform could support this model and which additional integrations, validation, governance or product capabilities would be required. /li liHelp structure an initial partner proposition and pilot blueprint, including responsibilities, milestones, evidence requirements, indicative resources and go/no-go decisions. /li liHighlight where additional scientific, clinical, regulatory, quality, manufacturing, legal or data expertise must be brought into the initiative. /li /ul pThis role does not involve performing laboratory research, assuming clinical responsibility, providing formal regulatory sign-off or acting as the sponsor or manufacturer of an ATMP. /p h3Who are you? /h3 ul liYou have at least b5 years of relevant experience /b in advanced therapies, translational medicine or a closely related regulated field. /li liYou hold an MSc, PhD, PharmD, MD or equivalent qualification in biotechnology, biomedical sciences, cell or molecular biology, genetics, immunology, regenerative medicine, tissue engineering, pharmaceutical sciences, medicine, bioengineering or bioprocess engineering. /li liYou have worked in biotech, pharma, a hospital advanced-therapies unit, SoHO establishment, translational research centre, GMP facility, CDMO, CRO or relevant regulatory environment. /li liYou have directly supported at least one cell, gene or tissue-based programme and helped move it between development stages. /li liYou understand several areas across translational science, SoHO/ATMP classification, CMC, GMP, clinical development, quality, patient follow-up or evidence generation. /li liYou can turn complex scientific and regulatory dependencies into clear priorities, stakeholder responsibilities and actionable next steps. /li liYou are comfortable challenging an early-stage thesis rather than simply validating what we already believe. /li /ul pExperience with Regulation (EU) 2024/1938, EMA/CAT, AEMPS, academic technology transfer, clinical-outcome monitoring or European research consortia is especially valuable. /p h3Engagement and future possibilities /h3 ul liThis is an initial six-week unpaid advisory engagement requiring approximately 2–3 hours per week. /li liYou will work directly with the Founder CEO to help shape MiMIAT’s emerging biotech model, validate its first advanced-therapy thesis and translate the vision into a credible development pathway. /li liAt the end of the six weeks, if there is a strong mutual fit and the initiative has progressed sufficiently, we may explore a continuing role as a programme lead, implementation or operating contributor, ongoing advisor or, where the alignment and commitment justify it, a member of the founding team behind the new structure. Any continuation (including responsibilities, time commitment, compensation and any potential equity) would be negotiated separately and documented in a formal written agreement. /li liThis exploratory engagement does not itself guarantee or create an entitlement to any future role, compensation, equity or appointment. /li liYou will have the opportunity to shape an emerging biotech model at the intersection of advanced therapies, patient‑centred data and translational development. /li /ul h3How to apply /h3 pSend your CV to or reach out directly here on LinkedIn. /p pPlease include a brief description of the most relevant advanced-therapy programme you have supported, the development stage involved and the responsibility you personally held. /p pAnd if this speaks to you, we’d love to hear from you! /p /p #J-18808-Ljbffr

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