In Vitro Diagnostics Development Lead

il y a 1 semaine

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **Devices Packaging department**, we are looking for a talented colleague to fill the position of**:In Vitro Diagnostics Development Lead - Braine L’Alleud**.

**About the role**:
The role has overall accountability for the In Vitro Diagnostics development strategy as well as oversight of the scientific investigations that enable regulatory In Vitro Diagnostics and CDx approval for UCB’s portfolio of therapeutic programs. The job tasks of this role include:

- Accountable for the In Vitro Diagnostics strategy and its ongoing review once an **In Vitro Diagnotics development** is triggered as an integral member of the clinical program
- Formulating the In Vitro Diagnostics development strategy, to include timelines and budget forecast. **Support fit-for purpose laboratory implementation of clinical trial assays, and lead transfer of clinical trial assays**, and steer transfer of clinical trial assays towards further development
- ** Guiding cross-functional teams** throughout In Vitro Diagnostics development, validation, submission, approval, commercialization, and deployment
- Support any internal or external biomarker assay development and its deployment in early clinical studies and lead later transfer to an In Vitro Diagnostics technology partner
- Accountability for project managing In Vitro Diagnostics and CDx technology partnerships to ensure timely and on-budget execution
- Supporting In Vitro Diagnostics technology partners in late-stage regulatory interactions from diagnostic / In Vitro Diagnostics strategy perspective
- Accountability for governance activities with In Vitro Diagnostics technology partners

**You will work with**:
You will speak at the highest levels internally and externally. You will translate complex technical data for non-specialist audiences. Further, you will negotiate and persuade both internal and external stakeholder with rational, reasoned arguments in support of positions to achieve common objectives.

**What you will do**:

- Accountable for the **In Vitro Diagnostics development strategy** and its ongoing review aligned with the In Vitro Diagnostics target product profile for assigned programs
- Accountable for the **formulation and life cycle management of the In Vitro Diagnostics development strategy** to include established upon timelines and budget forecast
- Lead internal cross functional teams which may include but not limited to biomarker leads, vendor leads, clinical operations, quality assurance and regulatory affairs representatives for the successful implementation of clinical trial assays and In Vitro Diagnostics assays, and diagnostic data collection in clinical trials
- Support regulatory In Vitro Diagnostics interactions by contributing to the writing and the review of In Vitro Diagnostics portions of briefing documents, informed consents, clinical protocols, schedule of activities, clinical study reports, regulatory submissions
- Drive and support **contracting with biomarker technology companies and In Vitro Diagnostics technology partners**. **Project manage the timely and on-budget delivery of In Vitro Diagnostics and CDx** from development to approval and launch
- Manage In Vitro Diagnostics technology partnerships, with identification of core vendors and implementation of ongoing governance
- As a technical Subject Matter Expert, manage day-to-day technical engagement with the partners
- Promote In Vitro Diagnostics awareness and good practices

**Interested? For this position you’ll need the following education, experience and skills**:

- You have a scientific master or higher
- You have min. 5 years working experience in the biotech/pharma
- You have a broad knowledge and comprehension of established and novel clinical biomarker and diagnostic assay technologies
- You are experienced in the drug development process (clinical trials, efficacy endpoints, biomarker testing, and implementation of biomarker assays in clinical development)
- You have a strong comprehension of the decision-making process in the biotech/pharma industry, and how diagnostic development strategy can influence drug development and commercialization
- You have a good comprehension of the In Vitro Diagnostics development process
- You have strong project management skills to manage multiple teams across a variety of personalized healthcare projects
- You can work collaboratively across business areas and with diverse functional stakeholders
- You can lead cross-functional and matrix teams
- You are fluent in English. Any other language is an asset
- Desired soft skills: communication/networking, influence/negotiation, organization, problem solver

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four

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