Biomarker Scientific Monitor and BMD Study ExpertCoordinator (80-100)

Salary Range:

CHF93800.00 - CHF174200.00

Band

Level 4

Job Description Summary

#LI-Hybrid
Location: Basel
Internal Title: Principal Scientist I

Laboratory Excellence and Operation (LEO) is the key global resource for Line functions (LF) and BR Clinical Trial Teams for biomarkers including biomarker outsourcing scientific biomarker monitoring vendor management biomarker logistics clinical site communication and sample coordination. LEO is working in close collaboration with clinical teams LF technology experts Biomarker Leads (BMLs) as well as specialized external service providers (ESP) central labs and clinical sites.

Job Description

Key Responsibilities:

• Act as a portfolio scientific monitor and oversee one or more strategic vendors. Lead development of strategic ESPs including on boarding planning communication oversight and act as a point of contact to ESP and SME at the BMD level. Leadthe implementation of innovative and global external solutions andbest practices across BMD
• Independently provide end-of-end support for exploratory and regulated biomarkers at external service providers (ESP) including placing implementing and monitoring biomarker assays (e.g. Immunoassay flow cytometry etc.) in TM clinical studies. Partner with ESP and internal teams to ensure on time/quality deliverables. Oversee regulated Biomarkers activities at ESPs within compliance requirements.
• Independently identify assay quality or performance issues. Resolve and engage LF SME clinical trial leaders data management and other teams in complex issue resolution and escalations
• Support data transfer and data flow (e.g. DTS etc.) for managed biomarkers and studies. Update study and project information in relevant IT systems
• Serve as a BMD Study Expert BSE and clinical team representative from BMD on selected clinical studies and/or at a project level. Partner with clinical teams and functions
• Collaborate with other TM and BMD functions and lead biomarker clinical operation processes continuous improvement initiatives and innovations in LEO and BMD.

Essential Responsibilities:

• MS in life science with 6 years of clinical operations experiences and/or clinical bioanalysis and/or clinical biomarkers
• PhD with 3 years in clinical operations and/or clinical bioanalysis and/or clinical biomarkers
• Emerging leader who is passionate about biomarkers operational innovation and partnership with external service providers/CROs and internal subject matter experts
• Laboratory knowledge and experience with one or several biomarker modalities and/or bioanalytical platforms e.g. immunoassays LC-MS/mass spectrometry cellular biomarkers
• Exposure to regulated bioanalysis/biomarkers and regulatory compliance is desired.
• Experience in troubleshooting of assays in CRO and assay transfer to CROs as well as managing relationship and performance of external service providers/CROs including specialized laboratories is highly desired.
• Deep knowledge of clinical study set up and clinical operations clinical sample analysis
• Extensive of the drug development process biomarkers and working with clinical translation research or global clinical studies
• Experience working in a global organization and matrix environment (multiple roles/connections and stakeholders)
• Strong global project management problem solving influencing communication and leadership skills.
• In depth/expert knowledge of regulatory requirements e.g. data integrity GCP GLP etc.
• Concise oral and written communication skills fluent in English as a working language

Benefits & Rewards

At Novartis were committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role:

• 93800.00 - 174200.00 CHF Annual

The base salary offered is determined based on gender-neutral objectives such as relevant skills competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally such as insurance plans retirement plans wellbeing resources and global recognition addition we provide flexible and hybrid working options where possible and minimum 14 weeks paid parental leave.

In addition to your base salary you may be eligible for a performance-based bonus depending on certain performance -term equity awards granted at group level may also be part of your package. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse equitable and inclusive environment that treats all employees with dignity and respect as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:

Benefits and compensation may vary by country and are subject to local legal requirements including provisions of collective bargaining agreements where applicable. A full overview of your compensation package including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO

Novartis is committed to building an outstanding inclusive work environment and diverseteamsrepresentativeof the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. Ifbecause of a medical condition or disability you need a reasonable accommodation for any part of therecruitment process or in order to receive more detailed information about the essential functions of a
position please send an e-mail to and let us know the nature ofyour request and your contact information. Please include the job requisition number in your message.

Skills Desired

Analytical Skill (Inactive) Analytical Skill (Inactive) Analytical Thinking Chemical Biology Chemistry Clinical Trials Collaboration Communication Skills (Inactive) Curious Mindset Data (Inactive) Data Analysis Design of Experiments (DOE) Detail-Oriented Drug Development Drug Discovery Process Ethics Gene Therapy Immunology Inventory Management Laboratory (Inactive) Leading Project Teams Lifesciences (Inactive) Machine Learning (ML) Management (Inactive) Medical Research 10 more

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1