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Chiesi USA

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 7,000 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. (https://www.chiesi.com/en/main-areas/)

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, inclusion, and equal opportunity 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.

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. This remote job with have a preferable candidate 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 clinical development plans, as well as authoring clinical sections of regulatory documentation.

+ Outstanding communication skills with ability to interact with and influence internal stakeholders and external academic and regulatory experts.

+ Strong understanding of GCP, regulatory requirements, and clinical trial methodologies.

+ Ability to interpret and effectively communicate complex clinical and scientific data, and literature.

+ Ability to successfully manage multiple tasks and resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities

Education

Medical Doctor Degree from a renowned institution; certification in Respiratory or Allergy & Immunology considered an advantage

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

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