Director/ Sr Director - Clinical Development (Respiratory)

JR Italy; Rimini; In loco; EUR 100.000 - 200.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development in Rimini. This pivotal role involves leading innovative drug development strategies in respiratory medicine, collaborating with global regulators, and mentoring clinical teams. The ideal candidate will possess extensive experience in pulmonary clinical practice and a strong background in the pharmaceutical industry. Join a forward-thinking company where you can make a significant impact on drug approval processes and contribute to the advancement of respiratory health.

Competenze

• 18+ years in pulmonary clinical practice, 5+ years in pharma/clinical drug development.
• Strong decision-making and influencing skills with good interpersonal abilities.

Mansioni

• Lead and manage Clinical Sciences respiratory projects, ensuring timely delivery.
• Review key study documents and provide guidance on subject eligibility and safety.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making skills

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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Director/ Sr Director - Clinical Development (Respiratory), Rimini

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EU work permit required:

Yes

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Job Reference:

7450231472016850944337130

Job Views:

1

Posted:

02.05.2025

Expiry Date:

16.06.2025

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Job Description:

Note: 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, including conception of 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. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals; review and due diligence of in-licensing respiratory molecules; and participation in ad 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 start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding.
• Support business development activities for respiratory programs, including portfolio management and lifecycle programs.
• Collaborate with internal stakeholders across various departments and participate in ad boards, forums, and regulatory discussions.
• Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

• MD / MS
• 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 the pharmaceutical industry or clinical projects in drug development.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Strong decision-making and influencing skills, with good interpersonal skills.