Nov 16, 2021

Job Description

As part of the Neuroscience (NS) and Autoimmunity, Transplantation & Inflammatory Disease (ATI) departments at Novartis, you will help to develop therapies for patients with neurologic or psychiatric disorders, as well as for patients who may benefit from a modulation of the immune system.

You will provide medical and scientific leadership and expertise in a role that significantly affects the entire Novartis NS and ATI drug development pipeline. You will drive the success of both early and late stage global programs. You will provide scientific expert assessments and support for in-licensing opportunities, including due diligences.

Your responsibilities will include:
1. Translational Medicine / early clinical projects:
• Develop high value decision-strategies for the Translational Medicine component of drug development projects from Research to clinical Proof of Concept or Proof of Mechanism in a single or multiple indications, including Parallel Indication Expansion-Proof of Concepts
• Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies), and other documents such as investigators brochures.
• Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study
• Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups)
• Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches

2. Translational Medicine (late-stage clinical projects):
In collaboration with the respective Translational Medicine Therapeutic Area Head:
• Responsible for implementing studies during the Proof of Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in Proof of Concept studies.
• Communicate clinical team matters to Global Project Teams, relevant Novartis Institutes of BioMedical Research and Global Drug Development boards, and other Novartis Boards as required.
• Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders
Matrix people responsibility per project 5-8 cross-functional members from Translational Medicine and other line functions per project team

Impact of this role?
• Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds
• This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof of Concept mechanism, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions
• As a recognized specialist in field, drives project team clinical strategy. Works globally across various Novartis Institutes and Divisions as well as country organizations as appropriate

Diversity & Inclusion / EEO

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

Minimum Requirements

Minimum requirements
What you will bring to the role:
• Medical Degree. PhD/post-doctoral and / or specialized further training (board certification) and / or clinical research experience in Clinical pharmacology.
• An expertise in translational medicine applied to neurology and immunology.
• Record of drug submissions / approval and / or high quality publications in international scientific journals.
• Previous relevant & significant clinical study experience: either from pharma/biotech leading early phase clinical trials; a senior role within a CRO responsible for managing the medical relationship with Sponsors; from a relevant academic medical center with PI & co-PI clinical trial experience.
• Business fluent in English (written and spoken)
Translational Medicine
Research & Development
Full Time
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Medical Director - Translational Medicine Expert (NS and ATI)

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