Global Program Clinical Head, Neuroscience (M.D.)

Legend Biotech USA; East Hanover (NJ); On-site; USD 261,000 - 485,000; Full time

Job summary

An established industry player is seeking a Global Program Clinical Head to lead clinical development in Neuroscience. This role involves overseeing a cross-functional team, ensuring the execution of clinical development plans, and engaging with external stakeholders. The ideal candidate will have a strong background in clinical research, particularly in Neuroscience, and a passion for innovation in clinical study designs. Join a mission-driven organization dedicated to improving lives through advanced therapies and become part of a collaborative team that values your expertise and contributions.

Qualifications

• 10+ years in clinical research or drug development in an industry environment.
• Advanced expertise in Neuroscience and clinical trial design.

Responsibilities

• Lead clinical development and strategy for Neuroscience programs.
• Drive transition of pre-PoC projects to Development Decision Point.

Skills

Clinical Research

Neuroscience

Leadership

Clinical Trials

Budget Management

Compliance

Risk Management

Cross-Functional Teams

Education

MD or PhD

Job description

Job Description Summary

Onsite
East Hanover, New Jersey

About the role:

With over 60 years 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, neurodegeneration, 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 for Neuroscience, leading clinical development and contributing to overall strategy in collaboration with other functions, to ensure the development and implementation of the Clinical Development plan. You will lead a cross-functional team of specialists and align early development plans with the overall strategy, oversee licensing evaluations, and develop and execute the disease area strategy.

Your Key Responsibilities:

• 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 more 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 expert, lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (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 implement publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing, and provide input into key external presentations.

Role Requirements:

Essential Requirements:

• MD, or PH. D degree with 10+ years’ experience in clinical research or drug development in an industry environment spanning clinical activities in Phases I-III/IV, including submission dossiers.
• A passion for Neuroscience
• Advanced expertise in Neuroscience 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.
• Detailed knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process.
• Demonstrated ability to establish strong scientific partnership with key stakeholders.
• 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.

Desired Requirements:

• MD or equivalent, MD or MD/PhD in Neurology, Experience in Cell & Gene, Rare or Neuromuscular diseases, Neuroinflammation of interest.

Novartis Compensation and Benefit Summary:

The pay range for this position at commencement of employment is expected to be between: $261,100 and $484,900/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities.

Why Novartis:

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

Accessibility and Reasonable Accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Salary Range: $225,400.00 - $418,600.00

Skills Desired: Budget Management, Clinical Trials, Coaching, Compliance, Cross-Functional Teams, Leadership, People Management, Risk Management, Risk Monitoring, Strategy