Franchise Clinical Operations Development Lead
il y a 3 semaines
FRANCHISE CLINICAL OPERATIONS DEVELOPMENT LEAD
- Biotech- GhentWHAT IS OFFERED
Franchise Clinical Operations Development Lead plays a critical role in overseeing the operational path for all indications within a franchise. Functioning as a line manager, and ensuring consistency to synergy across different indication teams. The Franchise Clinical Operations Development Lead has extensive external collaboration responsibilities with stakeholders beyond Clinical and R&D.
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 Franchise Clinical Operations Development Lead.
The Franchise Clinical Operations Development Lead is responsible for the strategizing, planning, leading and execution of the operational path for all indications within a franchise from first in human studies through authorization and commercialization. The franchise may involve several assets.
Key Responsibilities:
- Oversee the Clinical Operations Development Leads who provide strategic input and are accountable for all clinical related aspects within the assigned therapeutic indication/program, in line with the agreed timelines, budget and quality standards and as outlined in the applicable Standard Operation Procedures (SOPs) and Work Instructions (WIs).
- Oversee the Clinical Development Plan creation for all indications within the franchise.
- Acts as senior point of contact for all clinical related activities for a given franchise across asset indications. Collaborate with the asset teams as applicable.
- Focus on risks and mitigations on the franchise level. Ensure that the Global Head of Trial Operations is informed in case an identified issue/risk could have an impact on/may also occur in the other therapeutic indications/programs / franchises.
- Operationalise knowhow and synergies at the franchise level, ensure knowhow is shared with different indication teams.
- Ensure optimal implementation of lessons learnt within and across the franchises.
- Provides input to the relevant 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.
- As needed, participates in the CRO and vendor selection and management process.
- Acts as a point of escalation for resolution of trial management and operational issues within the franchise indications.
- Reviews and provides input to the overarching clinical program/indication documents such as Investigator Brochure (IB), Pediatric Investigation Plan (PIP), FDA/PMDA/EMA and other regulatory critical documents.
- Oversees the Indication and clinical trial budgets and timelines in collaboration with the Clinical Operations Development Leads and the Clinical Trial Managers.
- Oversees the resource requirements for Trial Operations within the franchise and ensures the needed resources are onboarded timely and efficiently
- Oversees audit/inspection readiness of the assigned program/trials. Support audits and inspections.
- Supports continuous improvement processes and consistency. Collaborates with the knowledge hubs with the TrialOps team.
- As seasoned Leader, sets expectations, communicates in a transparent, clear way and energizes and motivates the Clinical Operations Development Leads and the Clinical Trial Managers to work towards achieving the clinical goals.
- Collaborate on the franchise level with stakeholders outside of Clinical and R&D, eg Corporate Development, Science, Patient Advocacy Group (PAG), Medical Affairs and others.
REQUIRED COMPETENCES & SKILLS
- Bachelor’s or 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.
- Strategy as well as execution for clinical development.
- Change and risk management.
- Budget financial acumen.
- Rare disease and/or auto-immune clinical trial background relevant to the franchise.
- Proven track record in relevant leadership positions, including line management, within Clinical Operations in the pharmaceutical/biotech industries.
- Proven knowledge of planning and execution of clinical development plans and clinical trials.
- Experience in bu
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