Associate Director, Translational Medicine Expert, TM Clinical Pharmacology

Novartis

Job Location:

London - UK

Monthly Salary: Not Disclosed

Posted on: 20 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

As Associate 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.

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.

Location: London

Job Description

Key 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

Essential 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)

Skills Desired

Clinical Trials Data Analysis Data Monitoring Drug Development Drug Discovery Medical Strategy People Management

Required Experience:

Director

Job Description SummaryAs Associate 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 proje...