Clinical Program Leader

Chiesi Group; Parma; In loco; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Parma is seeking a Clinical Program Leader to oversee the development of innovative therapies. The ideal candidate has significant experience in R&D, particularly in clinical trials. This role focuses on strategic planning and execution of clinical studies, ensuring compliance with regulatory standards. The company offers a dynamic environment with flexible working arrangements and a commitment to staff development.

Servizi

Flexible working approach

Support in relocation process

Tax assistance for foreign colleagues

Competenze

• At least 5 years in an R&D role in the pharmaceutical/biotech industry.
• Experience in Interstitial Lung Disease preferred.
• Fluency in spoken and written English.

Mansioni

• Lead strategic planning and execution of clinical development programs.
• Provide clinical leadership within the Core Team.
• Engage with regulatory authorities and external experts.

Conoscenze

Strong scientific acumen

Matrix team leadership

Strategic vision

Outstanding communication skills

Formazione

Medical Doctor Degree

Descrizione del lavoro

Social network you want to login/join with:

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 assigned program. The CPL ensures scientific and medical integrity in the development and execution of clinical studies, leading clinical inputs 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.

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 (Interstitial Lung Disease) and experience in pharmaceutical /biotech industry are preferred and will be a plus.

Education

Medical Doctor Degree from a renowned institution; certification in Respiratory or Allergy & Immunology will be considered a plus

Languages

Fluency in spoken and written English

Technical Skills

• Experience in preparation of global clinical development plans, as well as authoring clinical sections of regulatory documentation and development of protocols and reports.
• 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

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.