R&D Project Leader Associate

工作内容

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment targeting perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO.

Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is headquartered in Liège, Belgium.

Mithra is looking for a Project Leader Associate to join its R&D department to work at Mithra headquarter (Liège).

As Project Leader associate, you will participate actively to pharmaceutical products’ development in collaboration with the Project Leader and will be responsible to manage and coordinate the projects in the most efficient way.

Within the Project Management department, you will report to the Project Leader and you will work with the project team and external stakeholders. You will focus on the extension of the Donesta clinical program.

• Coordinate the project(s) with the support of the project leader, which includes update of plans, timelines and budgets.
• Ensure a good knowledge of the different parts of the Project(s), and review essential documents if required.
• Ensure and manage interactions and follow-up with the internal stakeholders (CMC, RA, non-clinical, clinical, Medical, PV, etc) to ensure the good progression of the projects.
• Ensure and manage interactions and follow-up with the different external collaborators to ensure the good progression of the projects.
• Organize project meetings or others upon request, prepare for each meeting an agenda and the minutes.
• Constantly monitor and report on progress of the Project(s) to all stakeholders in collaboration with the Project Leader.
• Ensure the documentation traceability and archiving in collaboration with the Project Leader or the dedicated responsible.
• Collaborate closely with the accounting department for the follow-up of orders and invoices.
• Collaborate with the legal department for contractual aspect with sub-contractor under the supervision of the Project Leader or the dedicated responsible.
• For the allocated tasks, ensure the compliance with planning as defined with the responsible. In case of deviation, inform the Project Leader and suggest solutions.
• Perform risk management to minimize project risks in collaboration with the Project Leader

• Master or PhD in Biochemistry, Biology, Pharmacy, or equivalent
• Previous experience in Project management and/or in clinical development is an asset
• Knowledge of pharmaceutical product development is an asset
• Knowledge of GLP, GCP and GMP guidelines is an asset
• Autonomy and proactivity
• Excellent organization and coordination skills
• Good oral and written communication skills (English & French)
• Flexible, able to set priorities and solution oriented
• Good team skills and ability to work in an interdisciplinary and international environment
• Ability to work in an interdisciplinary environment
• Accuracy, discretion and precision
• Good written and oral communication skills
• Excellent organizational skills