Clinical Sciences Trial Leader (Trial Leadership) – Translational Medicine, Clinical Pharmacology (80-100%)

### **Summary** Location: Basel, Switzerland LI#-Hybrid We are seeking a Clinical Sciences Trial Leader (CSTL) to join Clinical Sciences & Innovation (CS&I) – Translational Medicine, in the Clinical Pharmacology team in Basel. This position plays a critical role in the delivery of first-in-human (FIH) and clinical pharmacology studies, representing a major step in the development of new medicines. You will be accountable for the scientific and operational leadership of clinical pharmacology trials, typically conducted in healthy volunteers, ensuring high quality, interpretable data to inform key program decisions. The CSTL role in Clinical Pharmacology is distinct in its strong focus on delivery through others. You will act as the primary bridge between Novartis and the qualified Contract Research Organizations (CROs) conducting clinical pharmacology studies, providing clear direction, oversight and integration from protocol development through to Clinical Study Report (CSR) delivery. This is a highly collaborative, hands-on role, requiring strong study leadership, excellent communication skills and confidence operating at the interface between internal teams and external partners. This position is based in Basel, with flexibility to work remotely for up to two days a week. Domestic and international travel may be required to support investigator meetings, study team engagement and trial oversight. Work permit support cannot be offered for this role. ### **About the Role** **Key Responsibilities** * + Provide **operational leadership** for assigned clinical pharmacology studies, including first-in-human and other early phase healthy volunteer trials. + Act as independent **Clinical Sciences Trial Leader** in the Clinical Pharmacology team, accountable for end-to-end‑ study delivery from protocol development through to CSR finalization. + Lead the **clinical pharmacology protocol synopsis development process**, serving as responsible author in close collaboration with Medical, Pharmacokinetics, Biomarker, Statistics and other cross-functional‑ partners to deliver the protocol synopsis that forms the basis for the selected CRO to develop into a full protocol. + Serve as the **primary Novartis point of contact to the CRO**, providing guidance, oversight and challenge to ensure high quality‑ study conduct and delivery. + Lead and coordinate internal cross-functional study teams, ensuring effective integration of inputs and alignment with CRO activities. + Oversee study start‑up, conduct and closeout, including review of key deliverables, issue management and risk mitigation. + Lead the **ongoing review of clinical study data**, including emerging PK, PD and safety data, supporting timely interpretation and decision making, e.g. for dose escalation decisions. + Contribute to **Clinical Study Reports (CSRs), internal decision documents and program updates**, ensuring clarity, scientific rigor and traceabilit