Translational Project Manager (1 of 2)

Job Description

1 purpose reimagine medicine!

As Translational Project Manager you will be responsible for implementing the biomarker strategy for Translational Clinical Oncology's (TCO) portfolio of clinical studies which range from targeted therapies to immunotherapies, Chimeric Antigen Receptor (CAR-T) and Radioligand Therapy (RLT) studies.

You will:

• Provide project management support of the clinical teams' requirements for i) new biomarker assay research, development and validation, ii) biomarker clinical testing, iii) review of assay specific performance data, iv) data visualization and interpretation.
• Provide input to study concept review board submissions to ensure biomarker assessments are operationally feasible. Responsible for reviewing biomarker relevant sections of clinical protocols and review of ICF template. Ensure line function head approval prior to submission to the protocol review committee (PRC).
• Ensure local data and biomarker sample collections are gathered in the CRFs. Provide input for biomarkers in to other clinical trial documents e.g. SAP, Data Review Plan, CSR and central lab documents including standardized sample collection instructions.
• Liaise with clinical teams to discuss data reporting requirements (format, content and agreed transfer process) to ensure that appropriate data transfer specifications are agreed prior to the start of clinical testing.
• Provide feedback via the clinical team to study sites/IRB's/Health Authorities on biomarker operational questions including generation of training materials for sites.
• Collaborate cross-functionally (e.g. QA) and cross-divisionally (e.g. EDO, NBS) to ensure compliance with Novartis quality systems for selecting and managing external vendors for clinical trials.
• Identify appropriate vendors and coordinate meetings to discuss vendor proposals. Work with vendor, clinical teams, and subject matter experts (SMEs) to ensure appropriate plan and budget is in place.
• Coordinate the technical assessment process with the respective SME maintaining the assay and biomarker portfolio information in appropriate repository (e.g. BLPT, TCB SharePoint.)
• Drive the biomarker outsourcing process through effective vendor management and project oversight (business conflicts, project status, adherence to budget, periodic provider appraisals, etc.) and resolve issues or raise in a timely manner as necessary.
• Facilitate the review of biomarker data by the clinical teams and SMEs both for internal review (e.g. CTT, EPT, translational science meeting) and externally (e.g. in dose escalation meetings) by ensuring biomarker data is available in-house and working with stats /SMEs/ bioinformatics on appropriate biomarker data outputs.

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.