Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

An innovative firm is seeking a seasoned clinical development leader to spearhead respiratory projects. This role involves managing clinical studies, engaging with global regulators, and driving drug development strategies. With a focus on collaboration and mentorship, the position offers an exciting opportunity to influence the future of respiratory medicine. The ideal candidate will have extensive experience in clinical practice and a deep understanding of regulatory interactions. Join a forward-thinking organization and make a significant impact in the healthcare industry.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Contribute to and review key study documents.
• Engage with regulators on clinical development pathways.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making skills

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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, 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. It involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review and due diligence of in-licensing respiratory molecules, and presentations at 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 or safety-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Participate in internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including lifecycle management programs.
• Collaborate with internal stakeholders across various departments and participate in ad boards, forums, and meetings. Engage with regulators on clinical development pathways for faster approvals.
• Develop projects and evaluate new business opportunities or internal target 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 as a practicing pulmonary clinical professional with over 5 years in the pharmaceutical industry or clinical projects involving clinical 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.