Clinical Program Lead

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels. 
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. 

 

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. 
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

 

Who we are looking for

 

 

Purpose

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. 

They ensure scientific and medical integrity in the development and execution of clinical studies, leading 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. The preferable candidate will be in the CST/EST time zones. 

Main Responsibilities

• Leads the strategic planning and high-quality execution of clinical development programs, 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.
• Clinical oversight of the design, implementation and operational delivery of clinical studies from early to late-stage drug development 
• Provides medical and scientific leadership to cross-functional teams, driving internal disease awareness and enhancing knowledge of the product landscape 
• Represents the company and clinical program in regulatory authority interactions, governance meetings and external partnerships, engages with external experts and key stakeholders to 
• 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.

Experience Required

• Significant experience in designing and executing a comprehensive clinical research & development plan.
• At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7-10 yrs in academia with clinical investigator track record.
• Experience within the specific therapeutic area is considered an advantage.
• Experience in development of protocols, reports and preparation of global clin