Clinical Pharmacology Trial Leader (Trial Leadership) – Translational Medicine

London - UK

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

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.

Location: London UK #LI-Hybrid

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Job Description

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 startup 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 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

Bachelors 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-inhuman 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

Job Description SummaryWe 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.T...