Translational Project Manager
Job Description Over 35 preclinical targets in our pipeline! Novartis Institutes for Biomedical Research (NIBR) Oncology strives to reimagine medicine for cancer patients through a combination of targeted immunotherapies including CAR-T, immune cell-engager, antibody drug conjugate and radioligand therapy.
The Translational Clinical Oncology team is looking for a Translational Project Manager to Lead the implementation of the biomarker strategy by providing project and vendor management support to assure the timely delivery and quality of biomarker data in oncology clinical trials.
What you will be doing:
*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 captured appropriately in the CRFs. Provide input for biomarkers into 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 escalate 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.
This role can be site based in Cambridge, MA or East Hanover NJ. It will not have the ability to be located remotely. EEO Statement 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 will bring to the role:
*Bachelor's Degree / Advanced degree.
*At least 5 years of experience in Research or Drug Development in Pharmaceutical Industry or with a CRO/Reference Lab/Central Lab.
*Basic to solid understanding of the clinical development process and the management of clinical trials.
*Basic to good understanding of contracts (including basic legal understanding of terms and conditions).
*Familiar with the CRO/Central Lab/Reference Lab marketplace.
*Experience of working in a regulated environment
*Demonstrated ability of completing projects on time and within budget.
*Excellent influencing and negotiation skills.
*Excellent written and oral communications skills.
*Strong problem-solving skills.
*Demonstrated willingness to make decisions and to take responsibility for such.
*Excellent interpersonal skills (team player).
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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
The pay range for this position at commencement of employment is expected to be between $97,600.00 and $146,400.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Work Location Cambridge, MA Company/Legal Entity NIBRI Functional Area Research & Development
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Novartis Group Companies
parental leave, paid time off, sick time, 401(k)
April 16, 2023