Nouscom, a clinical-stage biotechnology company developing next-generation immunotherapies to treat cancer across all stages, from early cancer interception to late-stage metastatic disease, today announced the appointment of Loredana Siani as Chief Technology Officer (CTO). We are looking for a Senior Clinical Scientist. The Senior Clinical Scientist owns the scientific and medical content of our clinical trial documents. The role turns our development strategy into well-designed protocols, delivery of clean data and defensible interpretation. The Senior Clinical Scientist works closely with Clinical Development leadership, Clinical Operations, Biostatistics, Regulatory Affairs, Translational Science, Drug Safety and external investigators. Job

Requirements:
• Advanced scientific or medical degree (PhD, PharmD, MD) in a life-sciences or clinical discipline, or an MSc in a relevant discipline with substantial equivalent experience in clinical development.
• Substantial experience as a clinical scientist in biotech or pharma, with demonstrable ownership of clinical study documents and data.
• Extensive experience in oncology clinical development.
• Proven track record in regulatory submissions, such as IND applications, CSRs or responses to health authorities, including direct participation in health-authority interactions, such as EMA Scientific Advice or FDA Type B meetings.
• Proven experience in protocol design & scientific authorship, clinical data interpretation and scientific communication, including peer-reviewed publications and presentations at major congresses (for example ASCO or ESMO). Preferred
• Familiarity with hereditary cancer syndromes, including Lynch syndrome, or with germline genetics.
• Established relationships with KOLs and cooperative research groups in oncology.
• Experience on internal scientific governance bodies, such as protocol review committees.
• Experience in a fast-moving, resource-conscious biotech where individuals carry broad scope. Technical skills
• Clinical development strategy. Translates program-level clinical strategy into study concepts and protocols, and contributes to clinical development plans.
• Protocol design. Strong command of early
- and late-phase protocol design: endpoint selection, inclusion and exclusion criteria, and operational feasibility. Authors protocols and amendments end to end.
• Oncology expertise.



Deep understanding of tumor biology, biomarkers and the specific complexities of oncology trials.
• GCP/ICH regulatory knowledge: Thorough working knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and FDA and EMA regulatory expectations; keeps own studies inspection-ready.
• Medical monitoring support. Supports safety reviews and the interpretation of emerging data in partnership with the medical monitor.
• Regulatory documents. Hands-on experience authoring clinical sections of clinical trial applications (CTAs), IND applications and briefing books, and contributing to the clinical modules of marketing applications (new drug applications, NDAs, and biologics license applications, BLAs).
• Clinical data interpretation. Identifies trends, assesses efficacy and safety signals, and provides evidence-based input to go/no-go recommendations.
• Cross-functional drug development knowledge. Understands how Biostatistics, Data Management, Clinical Operations and Regulatory Affairs work, and what each needs from the clinical scientist.
• Scientific communication. ability to craft clear scientific narratives for internal reviews, investigator meetings, advisory boards and publications.
• External relationships. Works effectively with external experts and investigators to refine study design and support recruitment.
• Risk identification. Spots recruitment, operational and scientific risks early, and proposes and escalates mitigation plans. Soft Skills
• Organizational agility: thriving in fast-paced biotech environments with evolving priorities.
• Rigorous and truthful with data. Separates what the data shows from what is inferred, and says so when evidence is ambiguous.
• Clear communicator. clear, concise, confident communication with governance bodies, senior leadership, and external stakeholders
• Comfortable with uncertainty. Makes sound, well-reasoned calls when answers are not clean, and flags risks early.




• Collaborative and low-ego. Influences across functions without formal authority.
• Ownership mindset. Takes a problem end to end rather than handing it off
• Mentorship & talent development: ability to coach junior scientists, build capability, and foster scientific excellence.

Responsibilities:
• Author and maintain core study documents: protocols, protocol amendments, informed consent form (ICF) templates and clinical study reports (CSRs).
• Provide day-to-day scientific and medical monitoring support for ongoing trials, including review of eligibility, safety signals and protocol deviations, in partnership with the medical monitor.
• Own clinical data review: define and drive data cleaning, perform medical review of data listings and ensure readiness for database lock.
• Contribute clinical-scientific content to regulatory submissions (IND applications, briefing books, responses to health authorities) and to interactions with the U.
S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other authorities.
• Translate translational and biomarker strategy into clinical endpoints, and work with Biostatistics on the statistical analysis plan (SAP).
• Prepare and present data at internal reviews, investigator meetings, safety committees and, where relevant, advisory boards.
• Support the clinical narrative for publications, congress abstracts, and investor and board materials, ensuring scientific accuracy.
• Build and maintain relationships with key opinion leaders (KOLs), investigators and cooperative research groups to refine study design and support recruitment.
• Act as a scientific point of contact for investigators, contract research organisations (CROs) and vendors.
• Coordinate the scientific work of other clinical scientists on shared programmes, and mentor junior colleagues.
• Identify scientific, operational and recruitment risks early and escalate them with a proposed mitigation. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. Nouscom is an equal opportunity employer. We welcome applications from all individuals. We are committed to treating all applicants fairly and avoiding discrimination.

📌 Senior Clinical Scientist (Roma)
🏢 NOUSCOM
📍 Roma