Clinical Pharmacology Trial Leader (Trial Leadership) – Translational Medicine
About this role
Job Description Summary
We are seeking a Clinical Pharmacology Trial Leader (CPTL) to join Clinical Sciences & Innovation (CSI) – Translational Medicine in our London office. This role may be appointed at standard or senior level, depending on prior experience and demonstrated scope of responsibility.
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 early clinical pharmacology trials, typically conducted in healthy volunteers, ensuring high quality, interpretable data to inform key programme decisions.
The CPTL role is distinct in its strong focus on delivery through others. You will act as the primary bridge between Novartis and the selected Contract Research Organisations (CROs) conducting the clinical pharmacology study, 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 at the Westworks London office, 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.
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.
- Skills Desired
- Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis