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.

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. 

Video Link  

• http://www.youtube.com/watch?v=ggbnzRY9z8w  

Role Requirements:

Essential Requirements:

• MD, PharmD, PHD degree with 6+ 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 Oncology
• Advanced expertise in Oncology 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

Desirable Requirements:

• MD license is highly preferred and desirable.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $284,000-$426,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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