Global Program Clinical Head - CVM

Novartis Farmacéutica; 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 programs across multiple indications. This pivotal role involves overseeing the design and execution of clinical development strategies that ensure successful regulatory approvals and market access. The ideal candidate will possess extensive experience in clinical research and drug development, particularly in cardiovascular diseases, and will demonstrate strong leadership skills to drive high-quality project outcomes. Join a dynamic team dedicated to improving patient lives through innovative science and collaborative efforts.

Benefits

401(k) eligibility

Paid time off benefits

Health care plans

Sign-on bonus

Restricted stock units

Discretionary awards

Qualifications

• 6+ years of clinical research experience required, with MD or equivalent.
• Advanced knowledge in clinical development and regulatory processes.

Responsibilities

• Lead Global Clinical Teams and represent Clinical Development on Global Program Teams.
• Develop and execute clinical strategies for regulatory approval.

Skills

Clinical Research

Drug Development

Cardiovascular Disease Expertise

Good Clinical Practice

Leadership Skills

Regulatory Submission Experience

Education

MD or equivalent

PhD

PharmD

Job description

The Global Program Clinical Head (GPCH) in CVM is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds. The GPCH owns the risk benefit assessment for the program(s), and as the leader of Global Clinical Team(s) (GCT) is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access.

About the Role

Major accountabilities:

• Leads the GCT, represents Clinical Development on the Global Program Team (GPT)
• May serve as the Clinical Development Representative on Biomedical Research clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
• May support Business Development & Licensing (BD&L) activities Post-DDP, leads the development and execution of the clinical strategy.
• Develops an endorsed 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
• Leads the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with IDP and TPP.
• Supports 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)
• Together with Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance. Serves as a core member of the Safety Management Team (SMT)
• As the medical expert, leads 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 (GMA), Marketing, Health Economics & Outcomes Research), and internal decision boards.

What you’ll bring to the role:

• MD or equivalent (preferred) PhD, or PharmD degree required
• 6 years professional experience with (MD or equivalent) OR 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers required
• Cardiovascular disease expertise, ideally experience with antithrombotic/anticoagulant drugs
• Advanced knowledge of assigned therapeutic area required, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process required
• Experience with submissions and health authorities required
• 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

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $261,100/year to $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. 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.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

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?

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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.

Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Division Development

Business Unit Innovative Medicines

Location USA

State New Jersey

Site East Hanover

Company / Legal Entity U014 (FCRS = US014) Novartis Pharmaceuticals Corporation