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Director Clinical Program Management
139691
Posted:
13th
February 2024
- 110000 EUR - 110000 EUR
- Ghent, Belgium
- Permanent
A leading, innovative European Biotech committed to bringing life changing treatments to those suffering severe and life-threatening auto-immune illnesses through the development of their cutting-edge portfolio of antibody products.
Position Overview:
If successful you will be tasked with overseeing all Clinical related activities within a specific Therapeutic Indication for your assigned asset. Working closely with your colleagues in the Medical & Scientific teams through the concept and execution of the Clinical Development plan as well as the end-to-end oversight of all operational activities including leadership of the Clinical Development Team.
Key Responsibilities:
Competencies and Qualifications:
Position Overview:
If successful you will be tasked with overseeing all Clinical related activities within a specific Therapeutic Indication for your assigned asset. Working closely with your colleagues in the Medical & Scientific teams through the concept and execution of the Clinical Development plan as well as the end-to-end oversight of all operational activities including leadership of the Clinical Development Team.
Key Responsibilities:
- Strategic Input & Accountability: All clinical related aspects within the assigned therapeutic indication/program and in line with the agreed timelines, budget and quality standards and as outlined in the applicable Standard Operation Procedures (SOPs) and Work Instructions (WIs).
- Clinical Development Plan: Ensure it describes the clinical development strategy, comprising effective and where possible innovative trial designs and is consistent with the target product profile. Ensures it is endorsed by the Asset Strategy Team and the Development Management Committee and is executed within agreed timelines and budget.
- Lead Responsibility: Alongside Medical colleagues, acts as primary point of contact for all clinical related activities for a given indication or across asset indications ).
- Risk Assessment: Conduct risk assessments and proactively address Clinical Development Trial -related timeline, budget, and milestone challenges and issues.
- Cross-functional Collaboration: Collaborate closely with various departments, including R&D, manufacturing, quality, and clinical teams, to ensure regulatory alignment throughout the product lifecycle.
- Health Authority Interactions: After completion of the Clinical Phase III program, Clinical Operations Development Lead and Medical Development Lead, in close collaboration with the CDT members, continue to be involved in the clinical related activities e.g., through input to different regulatory authorities (e.g., FDA, EMA, PMDA, MHRA).
- Project Management: Lead and manage regulatory CMC projects, ensuring timelines and objectives are met.
- Budgeting: Contribute to timeline and resource requirements and provides input to the financial CDT planning
Competencies and Qualifications:
- Minimum of 10 years of leading experience in Clinical Development including oversight of complex Clinical Development programs/portfolios within a Biotech or Pharma setting
- Hands on experience in the leadership of cross functional Clinical Development Teams as well as line management (Clinical Managers)
- Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. PhD degree is a plus.
- Rare disease and/or auto-immune clinical trial background is a plus.
Russell Smith
Division Director, DACH Region