Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Lucca; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Clinical Development Lead to spearhead the clinical development of groundbreaking respiratory drugs. This role involves collaborating with global regulators, managing clinical projects, and ensuring compliance with regulations. The ideal candidate will have extensive experience in pulmonary medicine and drug development, with a strong focus on mentoring teams and guiding strategic initiatives. Join this forward-thinking organization to make a significant impact on the future of respiratory healthcare and drive advancements in drug approval processes.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in pharmaceutical or clinical development projects.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents such as protocols and informed consents.
• Support business development for respiratory programs.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making and influencing skills

Good interpersonal skills

Formazione

MD or MS degree

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Job Description:

Note: The incumbent can be based anywhere in Europe or the US.

Role Overview:

This position is intended to head and support the clinical development of new drugs, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligned with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for drug approval, review and due diligence of in-licensing respiratory molecules, and participation in advisory boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.
• Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Review CRO medical monitoring capabilities during study startup and RFP processes, including CVs, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
• Support business development for respiratory programs, portfolio, medical affairs, and lifecycle management.
• Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings to discuss clinical development pathways and regulatory strategies.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

• MD or MS degree
• MD in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in pharmaceutical or clinical development projects, including regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Strong decision-making and influencing skills
• Good interpersonal skills