Global Program Clinical Head - East Hanover, United States - Novartis

Novartis

Verified Company

East Hanover, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

About the Role:

The ideal location for this role is East Hanover, NJ, but remote work may be possible (there may be restrictions based on legal entity).

Please note that this role would not provide relocation as a result.

If the associate is remote, all home office expenses and travel/lodging to the East Hanover or corporate site for periodic live meetings will be at the employee's expense.

The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.

10—that's how many pipeline projects Immunology has in Phase 3 or registration\\, with over 25 projects in Phase 1 or 2 Novartis' Immunology Unit has a pipeline with both depth and breadth and is known to be a talent powerhouse.

We are uniquely positioned to have a critical impact on bringing innovative medicines to patients across multiple disease areas.

The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.

As the leader of Global Clinical Team(s) (GCT), the GPCH is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements, market access, and owns the risk benefit-assessment for the program(s).

The GCPH contributes to the disease area strategy and is accountable specifically for the clinical development strategy.
Your responsibilities as GPCH will include the following: -Leading the GCT and representing Clinical Development on the Global Program Team (GPT)

May serve as the Clinical Development Representative on Novartis Institute for Biomedical Research (NIBR) Translational Medicine/project teams to drive progress of early projects to Transition Decision Point (TDP), including developing the Clinical Development Plan (CDP)
May support Business Development activities
Post-TDP, leading the execution of the CDP and contributing to the Integrated Development Plan (IDP) generated by multiple line functions, in line with the Target Product Profile (TPP), which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs
Leading the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistent with the CDP, IDP, and TPP. Supporting registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefitrisk assessment for license renewals) for the compound(s)
Together with Patient Safety, ensuring continuous evaluation of the drug safety profile, including safety monitoring of clinical studies and signal detection from postmarketing surveillance; serving as a core member of the Safety Management Team
As the medical expert, leading interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., NIBR Research, Translational Medicine, Medical Affairs, Commercial, Portfolio & Strategy, Health Economics & Outcomes Research), and internal decision boards

Diversity & Inclusion / EEO:

The Novartis Group of Companies 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:

What you'll bring to the role:

MD or equivalent with specialization and board-certification in Rheumatology
6 years professional experience (with MD or equivalent) in clinical research or drug development, in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers (required)
Strong Global team leadership skills and a capacity to work effectively and manage reports across time zones, while based out of our US headquarters in East Hanover, NJ
Advanced knowledge of assigned therapeutic area required, with the capability to innovate in clinical development study designs that provide relevant evidence to decisionmakers and to interpret, discuss, and present clinical trial and programlevel data

Why Novartis
766 million lives were touched by Novartis