Global Program Clinical Head

Novartis Group Companies; East Hanover (NJ); Hybrid; USD 284,000 - 426,000; Full time

Job summary

An established industry player is seeking a Global Program Clinical Head to lead the clinical development of an Oncology product. This role involves overseeing early clinical programs, collaborating with various functions, and developing comprehensive clinical strategies. You will manage a cross-functional team and engage with key stakeholders to ensure the success of the product. If you're passionate about Oncology and have significant experience in clinical research, this is an exciting opportunity to make a real impact in the field.

Qualifications

• 6+ years in clinical research or drug development, including Phases I-III/IV.
• Strong scientific partnership skills and leadership experience.

Responsibilities

• Lead clinical development strategies for Oncology products.
• Engage with stakeholders and ensure continuous safety evaluation.
• Create high-quality clinical documentation and support market access.

Skills

Clinical Research

Oncology Expertise

Data Interpretation

GCP Knowledge

Leadership Skills

Education

MD, PharmD, or PhD

Job description

Job Description Summary

Onsite
Location: East Hanover, New Jersey
Hybrid
#LI-Hybrid

About the role:

As Global Program Clinical Head (GPCH), you will lead the clinical development of an Oncology product, overseeing internal NIBR early clinical programs and external assets (BD&L) across Oncology (Solid Tumor) indications. You will contribute to the overall strategy, collaborate with functions like Regulatory Affairs and Market Access, and develop and implement the Clinical Development plan. You will lead a cross-functional team of specialists including Medical Directors, Trial Directors, Safety Leaders, Biostatisticians, and Regulatory Directors. Additionally, you will develop and execute the disease area strategy.

Job Responsibilities:

1. Provide clinical input supporting BD&L activities.
2. Drive the transition of pre-PoC projects to Development Decision Point (DDP).
3. Contribute to the Integrated Development Plan (IDP) aligned with the Target Product Profile (TPP).
4. Create and implement Clinical Development strategies for decision analysis and resource allocation.
5. Lead the creation of clinical documentation (Protocols, IBs, CSRs, regulatory documents) with high quality.
6. Engage with external stakeholders (regulators, KOLs, data monitoring committees, patient groups) and internal teams (Research, Medical Affairs, etc.).
7. Ensure continuous safety evaluation and signal detection from post-marketing surveillance.
8. Support registration, market access, and licensing activities.
9. Plan and execute publication and communication strategies in coordination with Medical Affairs.

The preferred location is East Hanover, NJ, but remote work may be considered with some restrictions. Travel and related expenses for periodic meetings at the site will be at the employee's expense. Working hours and travel expectations will be defined by the hiring manager.

Video Link:

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

Role Requirements:

Essential:

• MD, PharmD, PhD with 6+ years in clinical research or drug development, including Phases I-III/IV and submission dossiers.
• Passion for Oncology.
• Expertise in Oncology, innovative study design, and data interpretation.
• Knowledge of GCP, trial design, statistics, and regulatory processes.
• Strong scientific partnership skills.
• Leadership experience in a global/matrix environment.

Desirable:

• MD license is highly preferred.

Why Novartis: Join a community of passionate people dedicated to changing patients' lives. More info: https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn more at https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: Novartis is an Equal Opportunity Employer committed to diversity, inclusion, and non-discrimination based on race, gender, age, sexual orientation, disability, and other protected statuses.

Compensation: The salary range is $284,000 - $426,000/year, with potential bonuses, stock, and benefits. Final salary depends on experience, location, and other factors.

Join our Network: Sign up at https://talentnetwork.novartis.com/network to stay connected.

Accessibility: Reasonable accommodations are available. Contact [e-mail] or call [phone].