Clinical Program Leader

Chiesi Group • Cary, NC

7d

About The Position

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.

Requirements

• Medical Doctor Degree from a renowned institution
• 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 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.

Nice To Haves

• Certification in Respiratory or Allergy & Immunology
• Experience within the specific therapeutic area

Responsibilities

• Leads the strategic planning and high-quality execution of clinical development programs, ensuring scientific rigor and alignment with regulatory and business objectives.
• Provides clinical leadership within the Core Team, ensuring the clinical perspective informs key strategic decisions.
• Leads the Clinical Team in designing and executing a comprehensive global clinical development strategy from Phase 1 through Phase 4, optimizing study design and execution.
• Provides 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.
• Engages with regulatory authorities, external experts, and key stakeholders to shape development plans and ensure compliance with global regulatory requirements.
• Fosters innovation and continuous improvement in clinical trial design and execution to enhance patient outcomes and program efficiency.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree