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Digital R&D and Clinical Platforms Lead
hace 2 meses
We are seeking a highly skilled and experienced Digital R&D and Clinical Platforms Lead to join our team at 慓潮楦. As a key member of our organization, you will play a critical role in driving the development and implementation of cutting-edge technology solutions that support our research and development, clinical, and laboratory operations.
Main Responsibilities- Strategic Technology Liaison: Serve as the primary point of contact between our Global Science - Research & Development and Clinical functions and technology providers, ensuring seamless delivery of digital solutions for R&D information.
- Vendor Relationship Management: Establish and maintain strategic partnerships with technology vendors, overseeing the governance structures and ensuring alignment with our organizational goals.
- Digital Strategy Development: Develop and execute a comprehensive digital strategy for Research & Development and Clinical functions platforms, aligning with regulatory requirements and industry standards.
- Technical Solutions Leadership: Lead discussions on technical feasibility, prototype development, and the design of efficient, adaptable, and scalable technology solutions, ensuring compliance with company policies and regulatory standards.
- Technology Roadmap Execution: Manage the execution of the approved technology roadmap, ensuring the delivery of development and validation artifacts to meet high-quality standards, compliance, and audit readiness.
- Team Leadership: Build, mentor, and lead a high-performing team of digital experts focused on R&D and Clinical domains, fostering innovation and excellence.
- Vendor Collaboration: Foster strong collaboration with our software and support vendors to swiftly address and resolve problems or emergencies, ensuring continuous platform performance.
- Data Transformation: Leverage Data tools and strategies to transform and enhance R&D and clinical operations, streamlining processes, improving efficiency, and driving innovation in research and development, clinical trials, and consumer innovation practices.
- Contract and Inventory Management: Establish and maintain an inventory of R&D & Clinical Platform components, including their corresponding contracts and agreements for licensing and support, ensuring comprehensive oversight.
- Regulatory Compliance: Ensure that relevant digital platforms and processes comply with all relevant regulatory requirements, maintaining the highest standards of quality and safety.
- Financial Planning and Governance: Contribute to the annual digital investment, budgeting, and planning processes. Manage project budget requirements and actively participate in digital and R&D governance forums.
- Platform Compliance: Collaborate closely with relevant stakeholders to ensure that solutions, such as Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), Clinical Research Organization (CRO) integration, Clinical Trial Management Systems (CTMS), and Statistical Analysis System (SAS), are developed in accordance with the requirements of 21 CFR Part 11 and systems validation standards, ensuring regulatory compliance and data integrity.
We are looking for a highly experienced and skilled individual with a strong background in digital leadership roles within the Lifesciences or consumer healthcare industry. The ideal candidate will possess:
- A Bachelor's degree in a relevant field; Master's degree preferred.
- Proven experience (10+ years) implementing and supporting R&D and clinical platforms within Consumer Healthcare, biotechnology, and life sciences companies, ensuring efficient operations.
- Proficient in automating and maintaining scientific capabilities through Electronic Lab Notebooks, enhancing research efficiency and data management.
- Expertise in utilizing R&D SaaS platforms such as Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF), etc. to optimize business workflows and processes in quality-focused manufacturing production environments, improving operational efficiency.
- Exceptional leadership and team management skills.
- Excellent communication and stakeholder engagement abilities.
- Demonstrated ability in evaluating, negotiating, and managing contracts and Statements of Work with R&D technology vendors and implementation/support providers.
- Possesses comprehensive knowledge of Quality Assurance and regulatory compliance, including 21 CFR Part 11 and FDA regulations, ensuring technology solutions meet industry standards.
- Proven IT project leadership skills, including the capacity to gather clear business requirements and develop business cases with compelling value propositions, aligning technology initiatives with organizational goals.
- Strong communication, negotiation, and interpersonal skills.
- Demonstrated conflict resolution & problem-solving skills in a global environment.
- Strong appetite to learn and discover, entrepreneur mindset.
- Adaptable and open to change.
- Team player, service-oriented.
- Analytical and synthetic, able to formalize solutions, good writing skills.
- Strong oral and written communication skills.
- With leadership attitude, autonomy, and results-driven.
- Role model our 4 values: teamwork, integrity, respect, courage.
Fluent spoken and written English - French is an asset.
