Biomarker Clinical Operations Lead in PDG (m/f/d), Basel
Location:
Basel
Job Reference:
923988SDA_1738603252
Job Description:
The Biomarker Clinical Operations Lead in PDG at Roche/Genentech is responsible for providing biomarker operational expertise by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data for PDG clinical studies.
Background:
At Roche/Genentech Pharma Product Development (PD) Global Clinical Operations (PDG), we aim to transform drug development and deliver transformative medicines addressing diseases with the highest societal burden by 2029.
Tasks & Responsibilities:
1. Provide biomarker/IVD operational expertise to clinical study teams to ensure operational feasibility and quality data delivery.
2. Be accountable for the development of the BIOMARKER MANAGEMENT PLAN and execution of deliverables for assigned drug and device studies.
3. Manage all study level biomarker operations activities for both clinical and IVD studies.
4. Partner with internal/external stakeholders in the central lab set up.
5. Lead identification, selection, and oversight of BIOMARKER VENDORS.
6. Actively partner with Data Management to oversee and coordinate biomarker data format and delivery timelines.
7. Collaborate with cross-functional stakeholders to execute biomarker/IVD operational strategies.
8. Provide technical knowledge of aspects related to biomarker analyses.
9. Develop and oversee biomarker analysis timelines, budget, risk, compliance, and quality.
10. Attend operations team meetings and deliver presentations and trainings to stakeholders.
11. Provide responses to biomarker sample/IVD related questions from Health Authorities.
12. Identify areas of best practice and process improvements.
13. Work on business priorities as directed.
14. Expectation of ongoing and sustained onsite presence in compliance with local requirements.
Must Haves:
1. Minimum Bachelor/Master in Life Sciences.
2. 3+ years of experience in a clinical research setting.
3. Extensive clinical development experience with evidence of working in teams running clinical studies.
4. Strong experience with vendor and project management.
5. Knowledge of drug development process and respective regulations.
6. Clinical or laboratory experience with biological samples.
7. Experience working in a global and matrix environment.
8. Excellent collaboration, communication, influencing, and presentation skills.
9. Critical reasoning skills and problem resolution.
10. Detail oriented with the ability to manage multiple priorities.
11. Fluency in English; additional languages are an asset.
If you are interested in this position, please send us your complete dossier via the link in this advertisement.
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