344727BR
May 03, 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.

As an Operational Diagnostic Manager you will provide operational and scientific support to the Global Biomarker and Diagnostic Teams (GBDTs) implementing protein- and nucleic acid-based testing solutions for clinical trials and diagnostic co-development efforts with particular focus on Immuno-Oncology (IO) portfolio programs.

You will provide hands-on planning and operational support and technology expertise to ensure smooth development and maintenance of accurate diagnostic program plans, budgets and documentation. Deliver project management expertise to support GBDT’s I/O portfolio to ensure day-to-day operational excellence during the execution of biomarker and diagnostic packages required for clinical trials and global therapeutic health authority approval, launch, and lifecycle management.

Your responsibilities will include:
• Support scientific and technical elements of GBDT objectives under the guidance of the Head of Diagnostic and Molecular Pathology to support I/O clinical development clinical programs.
• Facilitate diagnostic program team’s strategy in scenario planning with clearly defined decision point ensuring timely delivery of technical assessments for both protein- and nucleic acid-based testing systems.
• Working cross-functionally with technical and subject matter experts (SME), regulatory and clinical team members to ensure developed assays and/or diagnostic tests meet required criteria and specifications.
• Provide project management support for assigned GBDT and for Joint Program Teams (JPTs) established with external diagnostic development partners or vendors, as well as pharmaceutical companies in case of joint efforts and collaboration programs. Establishing and maintaining an accurate program plan (activities, timelines and resources) for the diagnostic program to enable execution according to the approved GBDT strategy.
• Request document lists and document downloads from the various document and data management systems to provide to interested parties during due diligence activities, incl. IO market assessment with up-to-date diagnostic tests and specific requirements with interpretation guidance.
• Prepare documents and data lists for review by the respective line functions / technical and operational experts.
• Responsible for developing meeting agendas and for preparing clear and accurate meeting minutes.
• Responsible for quality, accuracy, and maintenance of technical assessment files under the guidance of the Head of Program, Portfolio and Alliance Management (or delegate) using relevant Novartis systems and tools.

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:
• Masters or Doctorate in life sciences/chemistry with 5 years minimum industry experience developing biomarker assays with particular focus on immunology and/or immuno-oncology subjects.
• Expertise in immunology and/or I/O, with a strong scientific background.
• Technical understanding of methodologies such as IHC and multiplexing with fluorescence application, in situ hybridization (ISH or FISH), usage of specific scoring guidance and analysis algorithms, RNAseq, qPCR, etc.
• Experience in implementation of biomarker strategies in clinical-stage programs; drafting and reviewing technical (assay validation report, IVD package, etc.) and regulatory documents (e.g., Pre-Sub, IDE, PMA) as well as clinical documents (e.g., protocol, lab manual, etc) preferred.
• Previous Program Management experience. Demonstrated track record of success working on an international multidisciplinary diagnostic development team, preferably in a complex matrix environment.
• Excellent verbal and written communication and presentation skills.
• Expert planning and tracking skills, with the ability to capture details and summarize in an integrated cross-functional plan. Proficient with MS Project.
• Ability to work in a dynamic work environment with cross-functional teams.
• Outstanding relationship-building and communication skills, including the ability to drive projects forward with external partners to meet specific timelines.
• Well organized, focused on results, capable of managing multiple projects, excellent time management skills.

This role can be based in either Cambridge, MA or East Hanover, NJ.

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
OHD GDD
USA
Cambridge, MA
Research & Development
Full Time
Regular
No
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344727BR

Operational Diagnostic Manager, Oncology Clinical Development

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