Clinical Pharmacology Trial Leader (FIH/Early-Phase)

DTX Pharma, a Novartis Company; Basel; Hybrid; CHF 94,000 - 174,000; Full time

Job summary

DTX Pharma, a Novartis Company, seeks a Clinical Sciences Trial Leader in Basel to lead first-in-human and clinical pharmacology studies, collaborating with CROs and internal teams. The role emphasizes end-to-end study delivery, protocol development, and data interpretation in PK/PD and safety.

The CSTL will bridge Novartis and CROs, driving quality study conduct, risk mitigation and timely CSR delivery in a hybrid Basel environment with some remote work possible.

Qualifications

• Bachelor’s degree in life sciences or healthcare required; advanced degree preferred.
• ~2+ years experience in clinical pharmacology, early clinical development or clinical trial delivery.
• Demonstrated experience contributing to or leading first‑in‑human and/or clinical pharmacology studies.
• Strong experience in protocol development, early phase study design and PK/PD/safety data interpretation.
• Proven ability to deliver studies through external partners, with CROs and outsourced trial management.
• Strong leadership and coordination skills; ability to align stakeholders in a matrix environment.
• Growth mindset and contribution to CSI culture.
• Solid understanding of ICH GCP and regulatory requirements for FIH studies.

Responsibilities

• Provide operational leadership for assigned clinical pharmacology studies, including FIH trials.
• Serve as independent CSTL, accountable for end-to-end study delivery from protocol to CSR.
• Lead protocol synopsis development with cross‑functional partners to hand to CROs.
• Act as primary Novartis contact to CROs, providing guidance and oversight.
• Coordinate internal cross‑functional study teams and align CRO activities.
• Oversee study start-up, conduct and closeout, including issue management and risk mitigation.
• Review emerging PK, PD and safety data to inform dose escalation decisions.
• Contribute to CSRs, internal decision documents and program updates with scientific rigor.
• Share lessons learned and promote continuous improvement in study delivery.
• Be a strong role model for collaboration, accountability and high standards.

Skills

Clinical pharmacology

Early clinical development

Trial delivery

CRO management

Study leadership

Protocol development

PK/PD interpretation

ICH GCP knowledge

Regulatory awareness

Education

Bachelor’s degree in life sciences

Advanced degree (MSc/PhD/PharmD/MD)

Job description

DTX Pharma, a Novartis Company, seeks a Clinical Sciences Trial Leader in Basel to lead first-in-human and clinical pharmacology studies, collaborating with CROs and internal teams. The role emphasizes end-to-end study delivery, protocol development, and data interpretation in PK/PD and safety.

The CSTL will bridge Novartis and CROs, driving quality study conduct, risk mitigation and timely CSR delivery in a hybrid Basel environment with some remote work possible.