Clinical Program Leader, Neonatology & Care

About the opportunity

Join a dynamic and dedicated Global Clinical Development team committed to advancing therapies for patients across a broad spectrum of neonatal and pediatric diseases, in line with Chiesi's long‑standing commitment to preterm infant care and neonatology.

This is what you will do

The Clinical Program Leader (CPL) is a core member of the cross‑functional R&D Global Core Team, playing a pivotal role in shaping the global clinical strategy and development for their assigned program. The CPL ensures scientific and medical integrity in the development and execution of clinical studies and leads clinical input into regulatory submissions and interactions.
This role requires strong scientific acumen, matrix team leadership, and strategic vision to drive the successful development and commercialization of innovative therapies in alignment with patient needs and global regulatory standards.

You will be responsible for

• Lead the strategic planning and high‑quality execution of clinical developmentprograms, ensuring scientific rigor and alignment with regulatory and business objectives.
• Provide clinical leadership within the Core Team, ensuring the clinical perspective informs key strategic decisions.
• Lead the Clinical Team in designing and executing a comprehensive global clinical development strategy from Phase 1 through Phase 4, optimizing study design and execution.
• Provide clinical oversight of the design, implementation and operational delivery of clinical studies from early to late‑stage drug development.
• Provide medical and scientific leadership to cross‑functional teams, driving internal disease awareness and enhancing knowledge of the product and competitive landscape.
• Represent the company and clinical program in regulatory authority interactions, governance meetings and external partnerships; engage with external experts and key stakeholders to inform development plans.
• Drive data‑driven decision‑making by interpreting clinical trial results and integrating findings into program strategy.
• Engage with regulatory authorities, external experts, and key stakeholders to shape development plans and ensure compliance with global regulatory requirements.
• Foster innovation and continuous improvement in clinical trial design and execution to enhance patient outcomes and program efficiency.
• Contribute to life‑cycle management activities for established neonatal products and to the design of innovative care models and technology‑enabled solutions in preterm infant care, in line with Chiesi's neonatology and special care portfolio.

You will need to have

• At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7–10 years in academia with a clinical investigator track record.
• Significant experience in designing and executing a comprehensive clinical research and development plan.
• Experience within the specific therapeutic area (neonatology) is highly desirable.
• Exceptional profiles with a slightly different experience mix may also be considered, with deviations from the above requirements evaluated on a case‑by‑case basis.
• Medical Doctor (MD) degree from a renowned institution.
• Postgraduate certification in Neonatology or Pediatrics (with NICU expertise) is highly desirable (may be considered an essential requirement depending on program needs).
• Fluency in spoken and written English.

Technical Skills

• Experience in development of clinical protocols, clinical study reports and preparation of global clinical development plans, as well as authoring clinical sections of regulatory documentation (e.g. IB, IMPD, CTD clinical modules, regulatory briefing documents).
• Strong understanding of GCP, global regulatory requirements and clinical trial methodologies.
• Outstanding communication skills with the ability to interact with and influence internal stakeholders and external academic and regulatory experts.
• Ability to interpret and effectively communicate complex clinical and scientific data and literature to diverse audiences (clinical, regulatory,commercial, external experts).
• Ability to successfully manage multiple tasks and resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities in a matrix, international environment.
• Ability to adapt to and work collaboratively within a number of teams, assuming leadership roles when appropriate.

Location

Europe, with possibility to work from remote