Clincal Development Operations
Il y a 2 mois
110000 EUR - 110000 EUR
- Ghent, Belgium
- Permanent
**About**:
Our client is a leading, innovative biotechnology company dedicated to developing cutting-edge antibody products to transform patients' with autoimmune disease lives. They are at the forefront of the immunology space, pioneering groundbreaking treatments for various diseases. Their mission is to revolutionize healthcare, and we're looking for a talented Clinical Operations Development Lead to join their dynamic team.
**Position Overview**:
We are looking to identify an experienced and highly motivated Clinical Operation/Development Lead to strengthen the Global Clinical Trial Operations team. In this key role, you will be responsible for co-leading the Clinical Development Team and co-owning the Clinical Development plan alongside the Medical Development Lead.
**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 Development Lead, 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
**Team Leadership**: As a Leader, sets expectations, communicates in a transparent, clear way and energises and motivates the team members as well as the respective Clinical Trial Managers to work towards achieving the clinical goals in line with the business goals and cultural pillars.
If applicable, acts as line manager of CTMs and/or CTAs:
- On-boarding of new direct reports
- Ensuring that assigned staff are trained
- Goal setting and review
- Mentoring and enabling the growth and development of assigned staff
- Supports ClinOps and Global Company initiatives as applicable.
**Competencies and Qualifications**:
- The Clinical Development Operations Lead excels in leadership and establishing good and effective internal and external working relationships and communication, embedding the company values.
- Global Strategic Drug Development experience and understanding.
- Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry.
- 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.
- Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management).
- Experience in working in an outsourced model, including overseeing CROs and vendors.
- Rare disease and/or auto-immune clinical trial background is a plus.
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