Clinical Pharmacology Leader

2 days ago

London, Greater London, United Kingdom Novartis Farmacéutica Full time

Novartis Biomedical Research (BR) is the innovation engine behind Novartis Farmacéutica, driving groundbreaking technologies that can revolutionize patient care. As a key component of BR, Translational Medicine (TM) plays a pivotal role in bringing innovative medicines to patients through cutting-edge research and development. TM Clinical Pharmacology is a cross-functional team specializing in designing, executing, and reporting First-in-Human (FiH) and Clinical Pharmacology studies across all TM therapeutic areas.

The operating model leverages strategic outsourcing partnerships with qualified and specialized Contract Research Organizations (CROs), allowing Novartis Farmacéutica to maintain sponsor oversight while retaining strategic elements of the studies. As a Medical Director, Clinical Pharmacology, you will join a dynamic team that significantly impacts the entire Novartis drug development pipeline.

This critical role involves providing medical and scientific leadership, as well as expertise, to support both early and late-stage global programs across all BR therapeutic areas. By doing so, you will contribute to the development of therapies for patients and enrich the Medical Team's expertise in Clinical Pharmacology.

About the Role

The Medical Director, Clinical Pharmacology, will be the primary point of contact for the cross-functional Clinical Pharmacology Trial Team and for our qualified CROs used in the Clinical Pharmacology Partnership Model for any safety-related, medical, and clinical pharmacology-related questions.

Key Responsibilities:

  • Contributing and providing Clinical Pharmacology expertise for the development of Study Concept Sheets and Protocols
  • Reviewing Informed Consent Forms, Statistical Analysis Plans, Tables, Listings, and Figure shells and drafts, and results summaries
  • Medical and Clinical Pharmacology coverage for Site Initiation Visits, during the clinical conduct of the trial, for safety reviews and safety reporting and for medical coding
  • Developing the Clinical Study Report and contributing to publications of study results, including abstracts, posters, manuscripts, plain language trial summaries, and technical results summaries

Clinical Pharmacology Strategy and Initiatives

  • Contributing to strategic initiatives and process optimization workstreams in TM Clinical Pharmacology
  • Strengthening collaboration with internal stakeholders in early and full development and external partners

Impact of this Role

  • This role has a significant impact on the entire Novartis pipeline by supporting the efficient clinical execution of FiH and Clinical Pharmacology studies for early and full clinical development programs in accordance with the Clinical Development Plan and Clinical Pharmacology Plan.
  • As a recognized specialist in the field, your strong experience in early clinical development and Clinical Pharmacology will enrich the Medical Team's expertise and help build and grow Clinical Pharmacology as the Novartis Center of Excellence for FIH and Clinical Pharmacology studies across all therapeutic areas in the BR portfolio.
  • The Medical Director, Clinical Pharmacology, will further help strengthen collaboration with our internal Novartis stakeholders in early and full development and establish efficient partnerships with our qualified CROs.

Salary Range: $180,000 - $220,000 per annum

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