Clinical Pharmacology Trial Leader (Trial Leadership) – Translational Medicine

Key Responsibilities

• Provide operational leadership for assigned clinical pharmacology studies, including first-in-human and other early phase healthy volunteer trials.
• Act as Clinical Pharmacology Trial Leader, accountable for end-to‑-end‑ study delivery from protocol development through to CSR finalisation.
• 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 close‑out, 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 programme updates, ensuring clarity, scientific rigour and traceability.
• Share lessons learned and contribute to continuous improvement of clinical pharmacology study delivery.
• Act as a strong role model within study teams, fostering effective collaboration, accountability and high standards of scientific and operational excellence.

Expected Prior Experience / Competencies

• Bachelor’s degree in life sciences or healthcare required; advanced degree (MSc, PhD, PharmD, MD or equivalent) preferred.
• Experience in clinical pharmacology, early clinical development or clinical trial delivery, ideally within a pharmaceutical environment, of the following durations:
  • CP Trial Leader ~2+ years
  • Senior CP Trial Leader ~6+ years
• Demonstrated experience contributing to or leading first-in‑human and/or clinical pharmacology studies, including healthy volunteer trials.
• Strong experience in protocol development, early phase‑ study design and clinical data interpretation, particularly PK/PD and safety data.
• Proven ability to deliver studies through external partners, with experience working closely with CROs and managing outsourced trial conduct.
• Strong study leadership and coordination skills, with the ability to align diverse stakeholders and drive delivery in a matrix environment.
• Comfortable operating with a high degree of personal ownership and accountability, managing complexity and ambiguity inherent in early phase‑ development.
• A clear growth mindset, with interest in developing own capabilities and contributing positively to team effectiveness and the wider CSI culture.
• Solid understanding of ICHGCP, regulatory requirements and high‑ quality‑ clinical trial conduct, particularly in the context of FIH studies.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.