Head of Device Product Development

About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Research & DevelopmentOur R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.

Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
Who we are looking forThis is what you will doReporting to the Sr. Director Device Development, the Head of Device Product Development is responsible for managing and overseeing Device Product Development department staff and activities, ensuring feasibility of design, development, manufacturing and testing of Medical Devices and Device Constituent Part of Drug Device combinations products in development and promoting cutting edge approaches and device solutions for device product development.
You will be responsible forSupport and oversee the department staff and ensure they work in accordance with company quality, device related cGMP, HSE requirements and regulationsSupport the department in the identification of the best design, development and manufacturing strategies from prototyping to product launchEnsure the identification and development of innovative device products, manufacturing and testing technologies suitable to support Chiesi’s strategyParticipate in Due Diligences for in-licensing opportunitiesSupport the definition of IP strategies and patentsScout, identify and manage as per applicable policies the strategic vendors for device related matters including design agencies, CMOs, test labs, consultants, etcEnsure the successful transfer of the device product and relevant manufacturing and testing specifications to Manufacturing or relevant CMOSupport the preparation and revision of relevant SOPs and processesIdentify, manage and develop the staff of the Device Product Development Department, ensuring that their technical skills and competences are aligned with the needs of the projectsAssure the people training, the development of competences and the appropriate allocation of resources and skills to relevant activities, are in compliance with company procedures and project needsEnsure the department acts as a centre of excellence for medical devices and combination products balancing internal capacity and competences with outsourcingContribute to the definition of the device projects portfolio and the required resources (CAPEX, OPEX, FTE) including the proposal communication to the managementResponsible for department adherence to safety and environmental rules and regulationsReview and approval of Design Controls documentationExpertise in medical device quality, risk management, manufacturing, and regulatory frameworks, including ISO 13485, ISO 14971, cGMP, and related global regulatory requirements.
You will need to haveSubstantial leadership experience within the development of drug-device combination product combining deep technical expertise with a strong understanding of regulated innovation environmentsExperience in managing, coaching and developing teamsThe candidate brings the credibility and strategic perspective that comes from many years of progressively broader leadership responsibilities in comparable roles.
Experience in successfully leading multidisciplinary organizations through periods of growth, transformation, and delivery, while developing both individual contributors and teamsCan demonstrate sustained accountability for strategic R&D activities from concept through commercialization, including contributing to the successful industrialisation and ongoing optimisation of produc