H4About us /h4pGRANITE BIO is a private biotechnology company located in Basel (Switzerland).brGRANITE BIO is supported by top-tier investors with ~$100M raised to date. Based on fundamental research conducted over the last two decades, GRANITE BIO’s is pursuing a differentiated approach to transform inflammatory, autoimmune, and fibrotic conditions. Both our programs are first-in-class monoclonal antibodies for large market opportunities in Immunology and Inflammation. GRT-001, the lead asset, depletes inflammatory monocytes. It has just completed a Phase 1a trial in healthy volunteers and has shown favorable safety and pharmacodynamic effect. The Phase 1b trial in patients with Ulcerative Colitis has just started. GRT-002 is an IL-3 neutralizing antibody that is thought to play an important role in type II inflammation.brOur company fosters an open, inter-disciplinary, diverse, international and creative working environment. We enable work-from-home options according to our internal workflows. The successful candidate will be highly motivated and enthusiastic with a positive “can do” attitude, attention to details and innovation, strong organizational and communication skills.brThe Associate Director / Director Study Lead will provide strategic and operational leadership across all aspects of clinical trial execution, including study planning, CRO/vendor oversight, study conduct, risk management, and trial closeout activities. This role is accountable for ensuring the successful delivery of clinical studies in alignment with corporate objectives, timelines, budget, quality expectations, and regulatory requirements.brReporting to the Head of Clinical Operations, the Associate Director / Director will play a critical leadership role within cross-functional study teams and will serve as a key operational partner internally and externally. The individual will ensure that clinical programs are executed efficiently and in compliance with SOPs, applicable regulations, CFR requirements, ICH-GCP standards, and global regulatory guidelines.brThe successful candidate will be a highly collaborative and proactive clinical operations leader with strong strategic thinking, problem-solving capabilities, and the ability to influence across functions and external partnerships. The ideal candidate will demonstrate excellent organizational, communication, and leadership skills, with a strong focus on quality, innovation, operational excellence, and continuous improvement. /pbrh4Responsibilities /h4pulliProvide strategic leadership and end-to-end operational oversight for global clinical trials from study start-up through database lock and closeout. /liliLead and manage relationships with CROs, vendors, and external partners, ensuring high-quality execution, performance oversight, and compliance with protocol requirements, SOPs, regulatory requirements, ICH-GCP guidelines, and quality standards. /liliServe as the operational study lead and primary point of accountability for clinical trial delivery, proactively driving timelines, quality, budget, and risk management. /liliOversee clinical trial budgets, forecasting, resource planning, vendor contracts, and invoice reconciliation to ensure financial accountability and operational efficiency. /liliProvide strategic oversight and review of study documents, operational plans, and working procedures; ensure appropriate training and alignment of internal and external study teams. /liliDrive study governance through proactive tracking of key milestones, KPIs, risks, and critical path activities, ensuring timely identification, escalation, and resolution of operational issues. /liliPartner cross-functionally with Clinical Development, Medical Monitoring, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Quality Assurance, and other stakeholders to ensure alignment on study objectives, deliverables, and timelines. /liliEnsure effective oversight of CROs and investigative sites to support timely, accurate, and inspection-ready clinical data and documentation. /liliProvide leadership oversight of Trial Master File (TMF) quality, completeness, and inspection readiness throughout the study lifecycle. /liliChair clinical trial team meetings, governance forums, and vendor oversight meetings; drive decision-making, accountability, and communication across stakeholders. /liliLead ongoing clinical risk assessment activities and ensure implementation of appropriate mitigation and contingency strategies in alignment with the Quality Management System (QMS). /liliIdentify opportunities for operational excellence and drive implementation of innovative processes, technologies, and best practices to optimize trial execution and delivery. /liliContribute to departmental initiatives, process improvements, SOP development, inspection readiness activities, and organizational scaling efforts. /liliMentor and provide operational guidance to Clinical Trial Managers and junior Clinical Operations team members as appropriate /li /ul /ph4Qualifications /h4pulliAdvanced scientific degree preferred (PharmD, PhD, MSc, or equivalent) in Life Sciences, Pharmacy, Medicine, or a related discipline; Bachelor’s degree with significant relevant experience will also be considered. /lili8–12+ years of progressive experience in clinical operations within the biotechnology, pharmaceutical, or CRO industry, including substantial sponsor-side experience. /liliProven experience leading global or regional clinical trials across Phase I–III studies, with accountability for study execution, CRO oversight, timelines, budgets, and risk management. /liliDemonstrated leadership experience as a Clinical Trial Lead, Study Lead, or equivalent role with increasing strategic and operational responsibilities. /liliStrong expertise in CRO/vendor management, including performance oversight, governance, contracting support, and issue escalation/resolution. /liliDeep understanding of ICH-GCP guidelines, FDA, EMA, and applicable global regulatory requirements, with demonstrated experience ensuring inspection readiness and quality compliance. /liliExperience working in cross-functional matrix organizations and effectively influencing internal and external stakeholders at multiple organizational levels. /liliStrong strategic thinking, analytical problem-solving, and decision-making capabilities, with the ability to manage complexity in a fast-paced environment. /liliExcellent organizational and project management skills with proven ability to manage multiple priorities and deliver high-quality results within timelines and budget. /liliExceptional communication, presentation, and interpersonal skills, with the ability to lead meetings, drive alignment, and communicate effectively with senior leadership, vendors, and study teams. /liliExperience in clinical risk management, quality oversight, and implementation of mitigation strategies throughout the clinical trial lifecycle. /liliDemonstrated ability to drive process improvements, operational excellence initiatives, and innovative approaches to trial execution. /liliProficiency with clinical trial systems and tools including CTMS, eTMF platforms, and Microsoft Office applications (Word, Excel, PowerPoint). /liliPrevious experience in biologics and/or early-phase clinical development (Phase I/II) strongly preferred. /liliTherapeutic area expertise in immunilogy preferred. /liliPrior people management and/or mentoring experience is considered a strong advantage for Director-level candidates. /li /ul /ph4What we currently offer /h4pstrongPrime Location /strongbrOur modern laboratories and offices are located in Tech Park Basel – a leading hub for early-stage start-ups.brstrongCommuter Benefits /strongbrWe support your individual commuting needs with parking options or a commuter allowance.brstrongFlexible Working /strongbrWe offer flexible working arrangements where possible.brstrongAdditional Time Off /strongbrIn addition to 24 days of annual leave, our offices and labs are closed between Christmas and New Year.brstrongYour Birthday Off /strongbrEnjoy an extra day off to celebrate your birthday.brstrongCoffee Connection /strongbrFree coffee and a great space to connect with colleagues.brstrongPersonal Development /strongbrWe support your professional and personal growth.brstrongCreative Environment /strongbrWork in an innovative, dynamic, and creative setting.brstrongDiverse Team /strongbrJoin an international team of passionate and talented people.brstrongTeam Events /strongbrRegular off-site summer and winter events to connect and have fun together.bremPlease note that these benefits are subject to change at the company’s discretion and do not constitute a contractual entitlement. /em /p