Clinical Operations Development Lead
il y a 3 semaines
CLINICAL OPERATIONS DEVELOPMENT LEAD
- Biotech- Ghent & remoteWHAT IS OFFERED
The Clinical Operations Development Lead plays a critical role in ensuring the success of clinical trials and the development of new therapeutic assets, coordinating efforts across various functions and stakeholders to drive effective clinical development strategies.
Next to a competitive salary with extensive benefits, we offer you the chance to grow and be a part of a team driven by creativity, innovation and science.
ABOUT THE COMPANY
MindCapture collabs with a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. They have established immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.
Together, we are looking to strengthen their Global Clinical Trial Operations team with a motivated and experienced Clinical Operations Development Lead.
The Clinical Operations Development Lead is responsible for overseeing clinical-related activities within a specific therapeutic indication or across all indications for an asset. They co-lead the Clinical Development Team and co-own the Clinical Development Plan with the Medical Development Lead. The Clinical Operations Development Lead ensures the clinical development strategy is executed in line with timelines, budget, and quality standards. They collaborate with the Project Managers and other stakeholders to achieve clinical goals.
Key Responsibilities:
- Provide strategic input and accountability for all clinical-related aspects within the assigned therapeutic indication/program.
- Collaborate to create the Clinical Development Plan, ensuring it aligns with the Target Product Profile and is endorsed by the Asset Strategy Team and the Development Management Committee
- Provide input to the Objectives, Goals, Strategies and Measures, and ensures that clinical trials are executed according to the Clinical Development Plan, following the internal procedures and processes and conducted in compliance with ICH-GCP and other applicable legislation.
- Act as the primary point of contact for all clinical-related activities within the assigned indication(s).
- Co-lead Clinical Development Team meetings, ensuring efficient discussions and documentation.Risk Identification and Mitigation: Identify risks, reflect them in risk registries, and drive their mitigation in collaboration with the PM.
- Act as the primary escalation point for resolution of trial management and operational issues within assigned indication(s).
- Oversee clinical trial budgets, timelines, and provide status updates.
- Review and provide input to critical clinical program/indication documents and ensure inspection readiness.
- Leadership and People Management: Set expectations, communicate transparently, and motivate team members. If applicable, act as a line manager for CTMs and/or CTAs.
REQUIRED COMPETENCES & SKILLS
- Bachelor’sor Master’s 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.
- Strong in leadership and establishing good and effective internal and external working relationships and communication.
- Global Strategic Drug Development experience and understanding.
- Strong interpersonal and stakeholder management Skills.
- Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry.
- Pro-active problem solver - demonstrated ability to identify and resolve issues, identify and mitigate risks, able to handle conflicts.
- Strong organisational skills, able to manage multiple and varied tasks and prioritize workload with attention to the holistic/ helicopter view but also able to dive into the details when needed.
- Strong people management skills, leadership skills and team player.
- Line management experience is a plus.
- Excellent written and verbal communication skills, acting globally in a culturally diverse dynamic team.
- Strong verbal and written English communication skills (primary fluency or full professional proficiency).
- Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.
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