Director, Translational Medicine Expert, Clinical Pharmacology

Novartis

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profile Job Location:

London - UK

profile Monthly Salary: Not Disclosed
Posted on: 15 hours ago
Vacancies: 1 Vacancy

Job Summary

Job Description Summary

As a Director Translational Medicine Expert (TME) Clinical Pharmacology (CP TME) you will serve as the primary medical and scientific leader for FiH and Clinical Pharmacology studies. You will partner closely with cross functional Clinical Pharmacology Trial Teams project level TMEs and CRO collaborators to ensure the highest standards of medical supervision participant safety and scientific quality.

TM Clinical Pharmacology is a crossfunctional expert group responsible for the design execution and reporting of FirstinHuman (FiH) and Clinical Pharmacology studies across all therapeutic areas. Operating through a strategic outsourcing model we partner with qualified CROs while maintaining strong sponsor oversight of all strategic elements including study design regulatory engagement and timelines.


Job Description

#LI-Hybrid

Location: This role is based in London United Kingdom. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Role Overview

As a Director Translational Medicine Expert (TME) Clinical Pharmacology (CP TME) you will serve as the primary medical and scientific leader for FiH and Clinical Pharmacology studies. You will partner closely with crossfunctional Clinical Pharmacology Trial Teams projectlevel TMEs and CRO collaborators to ensure the highest standards of medical supervision participant safety and scientific quality.

This role directly shapes early and full development programs across the BR portfolio and plays a critical part in delivering highquality data that informs program decisions and regulatory submissions.

Your Responsibilities

1. Clinical Pharmacology Portfolio Leadership

  • Lead and manage multiple FiH and Clinical Pharmacology studies simultaneously with medical scientific and operational excellence

  • Provide expert Clinical Pharmacology input into Study Concept Sheets protocols Informed Consent Forms Statistical Analysis Plans and TLF shells

  • Oversee medical and safety aspects of studies including Site Initiation Visits ongoing safety reviews medical coding and safety reporting

  • Drive development of Clinical Study Reports and contribute to dissemination of study results (e.g. abstracts posters manuscripts plainlanguage and technical summaries)

2. Clinical Pharmacology Strategy & CrossFunctional Collaboration

  • Provide strategic Clinical Pharmacology guidance to ensure optimal study design aligned with program objectives

  • Partner with projectlevel TMEs to align on compound background and program strategy

  • Lead or contribute to strategic initiatives process optimization and capabilitybuilding efforts within TM Clinical Pharmacology

  • Strengthen collaborations with internal stakeholders across early and full development as well as with external CRO partners

Impact of the Role

This role significantly influences the success of the Novartis development pipeline by:

  • Enabling efficient and highquality execution of FiH and Clinical Pharmacology studies

  • Delivering key data supporting program milestones and regulatory submissions

  • Strengthening Clinical Pharmacology as a Novartis Center of Excellence across all BR therapeutic areas

  • Elevating scientific and medical expertise within TM and across development teams

Minimum Requirements

  • Medical degree (MD) combined with a PhD/postdoctoral training board certification or relevant Clinical Pharmacology research experience

  • Significant experience in FiH and Clinical Pharmacology studieseither in biotech/pharma as a PI/subinvestigator at a CRO or at an academic medical center

  • Proven track record of contributions to drug development regulatory submissions or highquality scientific publications

  • Experience within a TM therapeutic area is an asset

  • Full professional proficiency in English (spoken and written)

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart passionate people like you. Collaborating supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Desired

Clinical Trials Cross-Functional Teams Data Analysis Data Monitoring Drug Development Drug Discovery Medical Research Medical Strategy People Management

Required Experience:

Director

Job Description SummaryAs a Director Translational Medicine Expert (TME) Clinical Pharmacology (CP TME) you will serve as the primary medical and scientific leader for FiH and Clinical Pharmacology studies. You will partner closely with cross functional Clinical Pharmacology Trial Teams project leve...
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Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.

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