Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Cuneo; Remoto; EUR 80.000 - 180.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a seasoned professional to lead the clinical development of new drugs, focusing on respiratory projects. This role is pivotal in planning and executing clinical studies, ensuring compliance with regulations while aligning with business objectives. The successful candidate will engage with global regulators, mentor project teams, and contribute to the strategic development of the respiratory portfolio. If you have extensive experience in pulmonary medicine and a passion for drug development, this is an exciting opportunity to drive impactful change in the industry.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects, ensuring timely delivery.
• Contribute to and review key study documents like protocols and informed consents.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Formazione

MD / MS

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 designed to lead and support the clinical development of new drugs, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in compliance 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 advisory boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all milestones.
• 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 for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical or safety 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 or escalating issues impacting 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, and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
• Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, new initiatives, and lifecycle management.
• Collaborate closely with internal stakeholders across various departments and participate in ad boards, respiratory forums, and meetings. Engage with regulators on clinical pathways and approval processes.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from 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 involving drug development and regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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