344496BR
Apr 28, 2022
USA

Job Description

769 million. That’s how many lives our products touch. At Novartis, being there when and how it matters most for our patients and customers allows us to live our purpose and help bring maximum impact to health outcomes.

Furthering our commitment to transforming medicine for patients, Novartis is embarking on an ambitious and exciting journey to reinvent how we use technology, data and customer insights to better serve our consumer’s needs and put them on a path to better health. This includes taking bold approaches that begin with a customer-centric mindset and harness the power of today’s digital and data-driven healthcare revolution to continue to improve and extend even more people’s lives.

• Do you want to help people understand their disease and how to seek out the proper treatment for it?
• Do you want to support patients achieve the best possible outcomes?
• Do you want to deliver a leading customer experience at all touchpoints?
• Do you want to be at the forefront of leveraging today’s technology advances to create tomorrow’s healthcare innovations?

We believe the answers are found when curious, adventurous, and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to utilize the power of digital and data to individualize and maximize interactions with customers.
Where you’re empowered to not fear failure when taking smart risks. And most importantly, where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

The Head of Early Phase in the Trial Monitoring Organization (TMO) will be accountable for planning, managing, and delivering Country level clinical trial activities of office and field-based associates to assure the delivery of early phase Global Oncology and Pharma clinical trials. Responsible for formulation of Early Phase clinical trial strategy in collaboration with other US TMO Leaders, NIBR, global stakeholders and Global Clinical teams, to assure effective trial execution and completion with high quality.

Key Responsibilities:

Trial Monitoring strategy
• Creates the Early Phase Trial Monitoring strategies by collaborating with NIBR and other US TMO Leaders to achieve Country objectives.
• Ensures effective communication within Country Trial Monitoring and Country medical Development Unit stakeholders, and NIBR to align and agree on Country level evaluation of projects, project deliverables, resourcing, issue escalation and resolution.
• Identifies and implements innovative practices and patient engagement strategies targeted to the Early Phase needs, within the Country, to advance clinical trial planning, execution, and quality.

Allocation, initiation and conduct of trials
• Manages the Early Phase country feasibility strategy to ensure strategic allocation and execution of trials within the Country.
• Ensures Early Phase trial milestones and trial budgets are delivered per established Country key performance indicators.

Delivery of quality data and compliance to quality standards
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements as it relates Early Phase clinical trial activities.
• Manages Early Phase issue identification, escalation and resolution aligned with the Country Head and by partnering with Country medical, GLF’s, NIBR, and Development/Country QA, as applicable.

Management of people and resources management
• Is responsible for hiring, developing, and retaining talent, within the Early Phase function
• Provides Trial Monitoring office and field-based resource requirements for Early Phase trial needs within the Country Monitoring structure in collaboration with Country Head and local Medical, NIBR (as appropriate).
• Communicates Early Phase specific training needs to the Country Trial Monitoring Head and TMO Training Quality and Compliance.
• Manages, develops, and recognizes Early Phase performance in line with Country Monitoring targets and objectives.

Budget and productivity
• Is responsible for the Country Early Phase clinical trial budgets (TCF management)

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:
• Bachelor’s Degree in life sciences required or advanced Degree in scientific or business preferred.
• 15 years of pharma industry experience in increasingly responsible leadership roles, and minimum of 8 years managing direct reports and a minimum of 5 years of experience in clinical study management.
• Excellent understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring.
• Strong capability in working in a Global/Country matrixed environment.
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards.
• Strong capability in working in a Global/Country matrixed environment.
• Established track record of leading successful teams, preferably with experience in working with international teams.
• Proven Strong leadership skills, strategic thinking skills and matrix management skills.

** This position can be based remotely anywhere in the U.S. (there may be some exceptions based on legal entity registration). Please note that this role would not provide relocation as a result.

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

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
GDO GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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344496BR

Head of Early Phase, US TMO (Remote)

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