Ph3About us /h3 pGRANITE BIO is a private biotechnology company located in Basel (Switzerland). /p pGRANITE BIO is supported by top-tier investors with ~$100M raised to date. /p pBased on fundamental research conducted over the last two decades, GRANITE BIO’s is pursuing a differentiated approach to transform inflammatory, autoimmune, and fibrotic conditions. /p pBoth 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. /p pOur company fosters an open, inter-disciplinary, diverse, international and creative working environment. We enable work-from-home options according to our internal workflows. /p pThe successful candidate will be highly motivated and enthusiastic with a positive “can do” attitude, attention to details and innovation, strong organizational and communication skills. /p pThe 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. /p pReporting 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. /p pThe 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. /p h3Responsibilities /h3 ul liProvide strategic leadership and end-to-end operational oversight for global clinical trials from study start-up through database lock and closeout. /li liLead 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. /li liServe as the operational study lead and primary point of accountability for clinical trial delivery, proactively driving timelines, quality, budget, and risk management. /li liOversee clinical trial budgets, forecasting, resource planning, vendor contracts, and invoice reconciliation to ensure financial accountability and operational efficiency. /li liProvide strategic oversight and review of study documents, operational plans, and working procedures; ensure appropriate training and alignment of internal and external study teams. /li liDrive study governance through proactive tracking of key milestones, KPIs, risks, and critical path activities, ensuring timely identification, escalation, and resolution of operational issues. /li liPartner 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. /li liEnsure effective oversight of CROs and investigative sites to support timely, accurate, and inspection-ready clinical data and documentation. /li liProvide leadership oversight of Trial Master File (TMF) quality, completeness, and inspection readiness throughout the study lifecycle. /li liChair clinical trial team meetings, governance forums, and vendor oversight meetings; drive decision-making, accountability, and communication across stakeholders. /li liLead ongoing clinical risk assessment activities and ensure implementation of appropriate mitigation and contingency strategies in alignment with the Quality Management System (QMS). /li liIdentify opportunities for operational excellence and drive implementation of innovative processes, technologies, and best practices to optimize trial execution and delivery. /li liContribute to departmental initiatives, process improvements, SOP development, inspection readiness activities, and organizational scaling efforts. /li liMentor and provide operational guidance to Clinical Trial Managers and junior Clinical Operations team members as appropriate. /li /ul h3Qualifications /h3 ul liAdvanced 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. /li li8–12+ years of progressive experience in clinical operations within the biotechnology, pharmaceutical, or CRO industry, including substantial sponsor-side experience. /li liProven experience leading global or regional clinical trials across Phase I–III studies, with accountability for study execution, CRO oversight, timelines, budgets, and risk management. /li liDemonstrated leadership experience as a Clinical Trial Lead, Study Lead, or equivalent role with increasing strategic and operational responsibilities. /li liStrong expertise in CRO/vendor management, including performance oversight, governance, contracting support, and issue escalation/resolution. /li liDeep understanding of ICH-GCP guidelines, FDA, EMA, and applicable global regulatory requirements, with demonstrated experience ensuring inspection readiness and quality compliance. /li liExperience working in cross-functional matrix organizations and effectively influencing internal and external stakeholders at multiple organizational levels. /li liStrong strategic thinking, analytical problem-solving, and decision-making capabilities, with the ability to manage complexity in a fast-paced environment. /li liExcellent organizational and project management skills with proven ability to manage multiple priorities and deliver high-quality results within timelines and budget. /li liExceptional communication, presentation, and interpersonal skills, with the ability to lead meetings, drive alignment, and communicate effectively with senior leadership, vendors, and study teams. /li liExperience in clinical risk management, quality oversight, and implementation of mitigation strategies throughout the clinical trial lifecycle. /li liDemonstrated ability to drive process improvements, operational excellence initiatives, and innovative approaches to trial execution. /li liProficiency with clinical trial systems and tools including CTMS, eTMF platforms, and Microsoft Office applications (Word, Excel, PowerPoint). /li liPrevious experience in biologics and/or early-phase clinical development (Phase I/II) strongly preferred. /li liTherapeutic area expertise in immunilogy preferred. /li liPrior people management and/or mentoring experience is considered a strong advantage for Director-level candidates. /li /ul h3What we currently offer /h3 pbPrime Location /b Our modern laboratories and offices are located in Tech Park Basel – a leading hub for early-stage start-ups. /p pbCommuter Benefits /b We support your individual commuting needs with parking options or a commuter allowance. /p pbFlexible Working /b We offer flexible working arrangements where possible. /p pbAdditional Time Off /b In addition to 24 days of annual leave, our offices and labs are closed between Christmas and New Year. /p pbYour Birthday Off /b Enjoy an extra day off to celebrate your birthday. /p pbCoffee Connection /b Free coffee and a great space to connect with colleagues. /p pbPersonal Development /b We support your professional and personal growth. /p pbCreative Environment /b Work in an innovative, dynamic, and creative setting. /p pbDiverse Team /b Join an international team of passionate and talented people. /p pbTeam Events /b Regular off‑site summer and winter events to connect and have fun together. /p pPlease note that these benefits are subject to change at the company’s discretion and do not constitute a contractual entitlement. /p /p #J-18808-Ljbffr