Medical Director, Translational Medicine - Cambridge, United States - Novartis

Novartis

Verified Company

Cambridge, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

About the Role:

This position can be located in Cambridge, MA or Basel, Switzerland and will not have the ability to be located remotely.

About the role:

2 Billion plus people are affected by diseases of the nervous system having a dramatic impact on patients and families around the world.

Neurologic and psychiatric diseases remain as some of the largest challenges in medicine. Novartis is committed to changing the landscape by developing transformative treatments for important neuroscience disorders.

As part of the Neuroscience (NS) departments at Novartis, you will help to develop therapies for patients with neuroimmunological disorders including multiple sclerosis.

You will provide medical and scientific leadership and expertise in a role that significantly affects the entire Novartis NS 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:

Translational Medicine (early clinical projects):

Develop high value decisionstrategies 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.
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

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 BioMedical Research and Development boards, and other Novartis Boards as required.
Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders
The work environment is in a matrix structure with crossfunctional members from Translational Medicine, Biomedical Research and Development.

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 decisionmaking, 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 Neuroimmunology, you drive the project team clinical strategy. Works globally across various Novartis divisions as well as country organizations as appropriate

Diversity & Inclusion / EEO:

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._

Role Requirements:

Essential Requirements

Medical Degree and advanced training in neuroimmunology
An expertise in translational or laboratory research. PhD preferred but not required
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 & coPI clinical trial experience.
Business fluent in English (written and spoken)

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