Global Program Clinical Head - Neuroscience

320875BR
Oct 04, 2021
USA

Job Description

60! With 60-year history in neuroscience, Novartis brought landmark therapies to patients with Multiple Sclerosis, Alzheimer’s disease, Parkinson’s Disease, Epilepsy, Depression and Migraine. We have a world-class pipeline in neuro-inflammation, neuro-degeneration, psychiatric and neuromuscular diseases. Our holistic R&D approach includes cutting edge molecules, comprehensive approaches to technology, biomarker and digital therapeutics to propose better solutions for patients worldwide.

As Global Program Clinical Head (GPCH) you are the clinical lead of a Neuroscience full development product and will be responsible for the clinical assessment of internal Novartis Institute for Biomedical Research (NIBR) early clinical programs and external assets (Business Development & Licensing - BD&L) across neurosciences indications.

As a key member of the Global Program Team, you will contribute to the overall strategy in collaboration with relevant other functions such as Regulatory Affairs, Market Access and others. You are responsible for developing and ensuring the implementation of the Clinical Development plan and leading a cross functional team of specialists such as Medical Directors, Trial Directors, Safety Leaders, Biostatisticians and Regulatory Directors. In addition, you will contribute to the development and execution of the disease area strategy.

What you’ll be doing:
• Responsible for clinical input to support Business Development & Licensing (BD&L) activities
• Serve as the Clinical Development Representative to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
• Contribute to Integrated Development Plan (IDP) 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.
• Drive creation and implementation of Clinical Development to support decision analysis and optimal resource allocation in program(s).
• Lead a cross functional team through the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency.
• As the medical professional, lead interactions with external partners (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal partners (e.g., Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcomes Research), and internal decision boards
• Together with Patient Safety, ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
• Support registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s)
• Plan and execute publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing, and provide input into key external presentations

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.

Minimum Requirements

What you’ll bring to the role:
• A passion for Neuroscience!
• PhD, or PharmD degree required.
• Advanced knowledge in Neuroscience required, with ability to innovate in clinical development study designs, provide relevant evidence to decision-makers and to interpret, discuss and present clinical trial or section program level data
• 6-10 years experience in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers required
• Detailed knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
• Demonstrated ability to establish strong scientific partnership with key partners
• Demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry

Desirable:
• MD or equivalent (preferred)

You’ll receive:
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme and learning and development opportunities as well.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.

Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis
Network here: https://talentnetwork.novartis.com/network

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Global Drug Development
CD&A GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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320875BR

Global Program Clinical Head - Neuroscience

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