Company Description
We are a leader in liquid biopsy. Every day we transform the lives of cancer patients and their families through the power of liquid biopsy. Our tests unlock essential genomic information from a simple blood test and allow clinicians to make more informed treatment decisions for their patients.
We are dynamic and innovative, focused on the development of new ground-breaking technologies in a fast-paced and international setting. Our exceptional team of talented and driven individuals work together to combine their energy and expertise in world-class research, product development and commercialization to bring new tests to the patients that need them.
If making a difference is in your DNA and you are ready to join the liquid biopsy revolution, then you could be just the person we are looking for to join our team based in Cambridge, UK!
Position
Role Overview:
Responsible for the delivery of new and improved products within the Inivata product portfolio from project initiation to product launch. Managing a cross-functional team members and stakeholders ensuring retention of focus of quality compliant delivery.
Key Responsibilities:
Management of the full life cycle of the product development project working cross-functionally with the Head of Assay Development, Director of Bioinformatics, Head of Science and Innovation, Quality, Regulatory and PMO teams as outlined in the project lifecycle phases below:
Start-up – work with relevant stakeholders to identify and document customer/user requirements and initial concept solutions.
Initiation – oversee completion of concept and requirement documentation, produce project timelines and milestones, implement risk and quality management and with cross-functional develop a robust business case for the project.
Execution – oversee and be accountable for progressing the project under stage gated design control procedures including verification and validation. Input into documentation where required. Lead manage and document design review meetings. Ensure completeness of design history file or technical file documentation suitable for regulatory compliance. Contribution to Companion Diagnostic projects as and when required.
Monitoring and Control – implement formal project management techniques and reporting relating to timelines, budgets, risk, quality, scope change. Chair and minute regular cross-functional product development project meetings and record key actions and decisions. Prepare regular presentations and report updates on progress to the executive team.
Closure – ensure completion of all documentation, facilitation of lessons learned, ensure post-market controls are in place and assist with ensuring development benefits realisation occurs.
Quality management:
Ensure that the project is developed to be compliant with the associated product regulatory pathway and work closely with the Quality Team to ensure regulatory completeness and compliance.
Risk and Issue management:
Document, assess, categorise, and monitor risks and issues relating to the project from both the product and business perspective. Ensure all key product development project decisions are logged.
Scope management:
Oversee the scope of the product project and escalate concerns to senior management where required.
Budget management:
Assist with construction and monitoring of product development budgets.
Benefits realisation:
Assist with the integration of product development projects where required into business-as-usual status to realise the business benefits for the project.
Governance:
Establish and maintain structures that clearly define roles, responsibilities, escalation procedures and accountabilities for the delivery and governance of the project.
PMO Office:
Contribute to process improvements with the PMO and assist with ensuring that best practice project management is employed across projects.
Provide regular feedback on product project progress to PMO program management.
Escalate product project related issues to PMO program management in a timely fashion for resolution.
HIPAA/GDPR Compliance: Position will
Agree to abide by Employment and Confidentiality Agreements and End User Policies
Commit to stay up to date on training requirements for HIPAA/GDPR
Understand the importance of the proper handling and disposal of ePHI and agrees to follow HIPAA/GDPR Regulations
Abide by the requirements for the proper disposal of equipment containing ePHI
Agree to report breaches and the improper handling of ePHI to the Company’s Privacy and Security Officers
Produce and adhere to proper validation documentation
Requirements
Skill Requirements:
Experience:
Minimum of five years demonstrated ability in Project Management roles in a fast paced, changing global IVD or Pharmaceutical environment while working under design control
Experience of successfully managing multiple product development projects simultaneously to high quality standards.
Experience with Companion Diagnostic Product Development Projects and processes, feasibility through to product launch
Knowledge:
Knowledge of medical device and clinical laboratory requirements including GCP/GCLP, CLIA, CAP, QSR, ISO13485, IVDD, IVDR and GMP manufacturing.
Familiarity with pre-submission packets 510k and PMA documentation for class II and Class III devices.
Assay development laboratory experience strongly preferred.
Knowledge of GxP software systems preferred.
Strong business and financial acumen.
Experience of budgeting, forecasting, and resourcing.
Education:
Educated to degree level in life sciences or engineering. .
Project Management certification (e.g. PMP/PRINCE2) preferred.
Communication:
Excellent leadership, communication, and negotiations skills with the capacity to empower team members and ability to build meaningful relationships with all levels of staff.
Ability to effectively navigate and motivate teams involved in product development processes via matrix management to implement best practice project management across functions including experience of resolving conflicts between teams.
Excellent written, verbal and presentation communication skills.
Information Technology:
Competent in usage of IT systems (MS Office, Atlassian, Jira and Confluence) preferred.
Experience of design history file management within a software system preferred.
Continuous Improvement:
Ability to proactively contribute to ongoing process improvement and lead change initiatives.
Other information
Our Values guide all our activities:
We are BOLD with the delivery of cutting edge science.
We are PASSIONATE we love what we do, our purpose and our impact on patients is clear
We are CARING we care for our patients, our partners, customers and colleagues
It is a requirement to have the right to work in the UK
Inivata Limited is based in Cambridge, UK.
No agencies please.
We look forward to reviewing your application!