Design & Development Program Manager

Design & Development Program Manager

CellCarta

Wilrijk, Belgium

Summary

As a D&D Program Manager, you will lead and oversee projects, collaborating with both internal teams and external clients (primarily pharmaceutical and biotech partners in oncology), to ensure timely and complete delivery in accordance with the CellCarta Quality System.

You will gain a comprehensive understanding of the entire business model and will often be the first to identify our customers' needs. As a CellCarta D&D Program Manager, you will be responsible for upholding the 3T principles: keeping the project on Task, on Track, and on Time.

You will need to be comfortable with the following:

• Actively listening to customers and building relationships to ensure client satisfaction;
• Managing pressure effectively;
• Prioritizing effectiveness over being right;
• If you're organized, analytically driven, have a strong technical background, and can thrive in a dynamic, high-complexity environment, this could be the perfect role for you.

Responsibilities

The D&D Program Manager is responsible for delivering clinical assays used in patient management decisions, ensuring the project stays within the agreed upon scope, timeline, and budget. This is achieved by coordinating various tasks performed by both internal and external partners. The D&D Program Manager ensures that the project adheres to CellCarta's ISO13485 quality system. His/Her responsibility begins before a clinical assay development is assigned to CellCarta and extends through the clinical validation of the assay.

More specifically, you will participate in the following:

• Lead a cross-functional team by actively engaging and aligning stakeholders to ensure successful assay development, deployment, and submissions that meet customer objectives;
• Take responsibility for managing high-profile assay D&D projects, carefully overseeing timelines and resources to ensure on-time delivery. Develop and communicate a long-term vision, while regularly conducting risk assessments to identify and address potential challenges. Proactively manage the assay, anticipate risks, and communicate them to the customer, offering alternative solutions when obstacles arise;
• Enhance efficiency and productivity by refining operational frameworks and optimizing processes. Conduct thorough evaluations to eliminate waste and continuously seek opportunities for improvement and innovation;
• Ensure all essential documents for internal and external submissions are prepared and managed to achieve timely assay readiness;
• Oversee study budget control;
• Maintain clear and professional communication with the sponsor, cross-functional project teams, and management throughout the study;
• Lead sponsor calls and meetings.

Education

• A Master's degree in Sciences, Biomedical Sciences, Pharmaceutical Sciences, Medical Biology, Medicine, or equivalent expertise gained through experience.

Main Requirements

• 6+ years of project management, and/or CRA (Clinical Research Associate) experience, or a background in genomics or histopathology laboratories;
• A strong curiosity and eagerness to learn, coupled with a humble and teachable attitude;
• Proven track record of successfully managing (complex) projects to completion with excellent feedback, and the ability to prioritize multiple opportunities effectively;
• Exceptional communication skills, fluent in English, with the ability to write clearly and present ideas persuasively;
• Proficient in Microsoft Office (Word, Excel, PowerPoint, PowerBI);
• Excellent organizational skills with the ability to multitask;
• Positive, energetic, and proactive attitude;
• Able to take initiative, adapt, and thrive in a dynamic environment;
• Detail-oriented with strong diligence;
• Capable of working both independently and as part of a team;
• Strong critical thinking and problem-solving skills;
• Customer and project management service-oriented;
• A solution-focused mindset with a persistent, can-do attitude.

It's a plus, though not required, if you have:

• Experience with ISO13485;
• Background in cancer research, with an understanding of clinical laboratory operations, assay/instrument principles related to in vitro diagnostic product design and usage, and the scientific, statistical, regulatory, and compliance requirements of clinical research;
• Experience working in CAP, CLIA, and GCP environments, with a solid understanding of EMA and/or FDA guidelines for clinical trials;
• Experience working in global settings.

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