Stellenbeschreibungh4About 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. /pbrh4Responsibilities /h4pulliDesign, execution/conduct and report of Ph1/2 clinical trials in II space /liliContribute to medical team and clinical development strategy /liliProvide guidance and expertise in the development of clinical trial protocols and further study relevant documents, such as ICF, IB, SoA, TPP, SAP etc /liliEnsure that safety and efficacy data is generated and analyzed according to GCP/SOPs, corporate strategy and timelines /liliPerform medical monitoring activities (such as medical oversight of the study, answer questions about eligibility, review safety and adverse event data, medical oversight of coding activities) /liliWork closely with cross-functional team members to ensure planning and execution of clinical trials to meet key study milestones /liliPlay a key role in the development of statistical analysis plan, and in the review, interpretation, and communication of clinical trial data from clinical trials /liliAuthor and develop clinical documents like, clinical study protocols and amendments and review other clinical documents like safety management plan, medical monitoring plan /liliWork closely with colleagues from Clinical Operations and Clinical Biomarker department to deliver clinical study program goals and milestones /li /ul /ph4Qualifications /h4pulliAdvanced medical degree (MD or equivalent) /liliAt least 3 years of experience in clinical research or clinical development within the pharmaceutical or biotechnology industry, ideally with exposure to early clinical trials /liliStrong ability to build collaborative working relationships with physicians, expert consultants, and external vendors /liliStrong analytical mindset with excellent written and verbal communication skills /liliExceptional attention to detail, sound judgement, and strong organisational skills /liliSolid knowledge of clinical trial methodology as well as regulatory and compliance requirements for clinical trials /liliGood understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and clinical study design /liliUnderstanding of the framework and complexities of early multi-centre clinical trials, including working with CROs and CDOs /liliIdeally, experience in autoimmune disease and/or the IBD / inflammation and immunology (II) space /liliEffective communicator who shares information transparently and strategically /liliTeam player with strong listening skills /liliComfortable working in a dynamic, fit-for-purpose biotech environment /liliAble to thrive in collaborative and sometimes ambiguous settings, with a proactive and solution-oriented mindset /liliStrong planning, organisational, and problem-solving skills, with the ability to support efficient operational execution of clinical programmes, studies, and related projects /liliEnjoys contributing to diverse teams, whether in a leading role or as an active team member /liliTalented, proactive, and passionate medical professional inspired by the opportunity to bring innovation to patients with unmet medical needs /li /ul /ph4What we currently offer /h4pPrime LocationbrOur modern laboratories and offices are located in Tech Park Basel – a leading hub for early-stage start-ups.brCommuter BenefitsbrWe support your individual commuting needs with parking options or a commuter allowance.brFlexible WorkingbrWe offer flexible working arrangements where possible.brAdditional Time OffbrIn addition to 24 days of annual leave, our offices and labs are closed between Christmas and New Year.brYour Birthday OffbrEnjoy an extra day off to celebrate your birthday.brCoffee ConnectionbrFree coffee and a great space to connect with colleagues.brPersonal DevelopmentbrWe support your professional and personal growth.brCreative EnvironmentbrWork in an innovative, dynamic, and creative setting.brDiverse TeambrJoin an international team of passionate and talented people.brTeam EventsbrRegular 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