Medical Director

Vor 7 Stunden

Basel, Basel-Stadt, Schweiz Granite Bio AG Vollzeit
h3About us /h3pGRANITE BIO is a private biotechnology company located in Basel (Switzerland). /ppGRANITE 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. /ppOur 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. /ph3Responsibilities /h3ulliDesign, 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 /ulh3Qualifications /h3ulliAdvanced 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 /ulh3What we currently offer /h3pPrime Location /ppOur modern laboratories and offices are located in Tech Park Basel – a leading hub for early-stage start-ups. /ppCommuter Benefits /ppWe support your individual commuting needs with parking options or a commuter allowance. /ppFlexible Working /ppWe offer flexible working arrangements where possible. /ppAdditional Time Off /ppIn addition to 24 days of annual leave, our offices and labs are closed between Christmas and New Year. /ppYour Birthday Off /ppEnjoy an extra day off to celebrate your birthday. /ppCoffee Connection /ppFree coffee and a great space to connect with colleagues. /ppPersonal Development /ppWe support your professional and personal growth. /ppCreative Environment /ppWork in an