Clinical Sciences Trial Leader, Clinical Pharmacology (80-100%)

About the role

Novartis is looking for a Clinical Sciences Trial Leader (CSTL) for its Clinical Sciences & Innovation (CSI) Translational Medicine, Clinical Pharmacology team in Basel. The role leads first-in-human and early-phase clinical pharmacology studies in healthy volunteers, acting as the main bridge between Novartis and the CROs that run them, from protocol development through to Clinical Study Report delivery. It is a hybrid position with up to two days of remote work per week, and domestic and international travel may be required.

Key responsibilities

• Provide operational leadership for assigned clinical pharmacology studies, including first-in-human and other early-phase healthy volunteer trials.
• Act as independent CSTL, accountable for end-to-end study delivery from protocol development to CSR finalization.
• Lead the protocol synopsis development process with Medical, Pharmacokinetics, Biomarker, Statistics and other partners.
• Serve as the primary Novartis contact to the CRO, giving guidance, oversight and challenge.
• Lead and coordinate internal cross-functional study teams and oversee study start-up, conduct and closeout, including issue management and risk mitigation.
• Review clinical study data, including emerging PK, PD and safety data, and contribute to CSRs, internal decision documents and program updates.
• Share lessons learned and contribute to continuous improvement of study delivery.

Required profile

• Bachelor's degree in life sciences or healthcare; advanced degree (MSc, PhD, PharmD, MD or equivalent) preferred.
• ~2+ years of experience in clinical pharmacology, early clinical development or clinical trial delivery, ideally in a pharmaceutical environment.
• Demonstrated experience leading or contributing to first-in-human and clinical pharmacology studies, including healthy volunteer trials.
• Proven ability to deliver studies through external partners and manage outsourced trial conduct with CROs.
• Strong study leadership, coordination and stakeholder alignment skills in a matrix environment.
• Solid understanding of ICH GCP and regulatory requirements for early-phase studies.

Required skills

• Protocol development and early-phase study design
• Clinical data interpretation, especially PK/PD and safety data
• ICH GCP and regulatory requirements

What we offer

• Annual base salary range of CHF 93,800 to 174,200, with a possible performance-based bonus.
• Flexible and hybrid working options where possible.
• Minimum 14 weeks of paid parental leave.
• Insurance plans, retirement plans, wellbeing resources and long-term equity awards (details given during the application process).