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Director clinical sciences/ clinical development*

Immatics
Director
Inserat online seit: 31 Januar
Beschreibung

ABOUT US Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. OVERVIEW We are currently seeking a full- or part-time (min. 35 hrs/ week) Director Clinical Sciences/ Clinical Development* to strengthen our Clinical Sciences department. You will either work in one of our office locations in Tübingen or Munich, or remote (Germany) in an interdisciplinary environment with colleagues from Germany and the US and will contribute to our mission of delivering novel PRAME immunotherapies to patients with cancer. This role will be responsible for overseeing key aspects of clinical trial design and documentation, collaborating closely with interdisciplinary teams to ensure the successful clinical development of investigational medicinal products (IMPs). It reports directly to the Vice President of Clinical Sciences. YOUR MISSION Your main responsibilities will include but are not limited to the following tasks: Drive the clinical development (phase 1 to 3) of cancer immunotherapies in various solid tumor indications currently focused on two bi-specific molecules targeting two different tumor targets. Lead and oversee (Senior) Managers Clinical Sciences (direct reports). Provide strategic input into advisory boards and KOL interactions, ensuring stakeholder alignment on clinical aspects including target medicine profile, tumor indication and trial design. Lead cross-functional teams for preparation of regulatory (IND and CTA) submissions and subsequent submissions of amendments, addressing clinical/ scientific and procedural topics and integrating preclinical data, biomarkers, and competitive intelligence into trial designs. Author and manage the development of clinical trial synopsis/ protocols (CTPs) and related amendments, clinical trial reports (CTRs), patient information sheets and informed consent forms (PIS-ICFs), and other patient-facing materials in alignment with cross-functional teams. Prepare and review clinical sections of briefing books for US (FDA) and Europe (e.g., PEI in Germany). Ensure prompt responses on clinical aspects to regulatory and ethical review bodies. Prepare and review clinical sections of, e.g., investigator brochures (IB), and development and safety update reports (DSURs). Conduct trainings (e.g., CTP) to clinical sites, internal teams, and external partners, ensuring CTP accuracy. Establish functional plans and oversee the development, maintenance, and compliance of controlled documents (e.g., SOPs and Working Instructions) within Clinical Sciences. Manage internal and external stakeholders, organize data review meetings to analyze clinical trial data. Provide technical or subject matter expertise in clinical research programs. YOUR PROFILE Master’s degree or PhD (preferred) in Biology, Clinical Sciences, or Life Sciences. Minimum of 7 years’ experience in clinical trial conduct, with comprehensive knowledge of Good Clinical Practice (GCP) and a strong understanding of clinical development processes. Proven ability to lead cross-functional teams and ensure accurate clinical documentation within a regulated environment. Experience in the development of therapies for oncological indications is strongly preferred. Excellent verbal and written communication skills in both English and German. Ability to work independently while collaborating effectively in an interdisciplinary setting. Demonstrated flexibility and adaptability in dynamic and evolving environments. Proactive mindset combined with a structured and methodical approach to work. WHY US? We are the global leader in precision targeting of PRAME. Driven by our mission to make an impact on the lives of patients with cancer, we are a committed and inspired team and cherish the collegial, highly motivated, and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events. NOTICE *We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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