Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Modena; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development in Pulmonology to lead the development of innovative respiratory drugs. This pivotal role requires extensive experience in clinical pulmonary practices and regulatory interactions. You'll spearhead clinical studies, engage with global regulators, and mentor a talented team, ensuring compliance and excellence in drug development. Join a forward-thinking company committed to advancing respiratory health and making a significant impact in the pharmaceutical landscape.

Competenze

• Minimum 18 years of clinical pulmonary experience.
• At least 5 years in pharmaceutical clinical development.

Mansioni

• Lead and mentor clinical sciences respiratory projects.
• Review key study documents and assess CRO capabilities.
• Participate in medical monitoring safety meetings.

Conoscenze

Drug development expertise

Scientific advocacy and regulatory engagement

Decision-making skills

Interpersonal skills

Formazione

MD or MS degree in Internal Medicine

Specialization in Pulmonary/Critical Care Medicine

Descrizione del lavoro

Below is a refined version of the job description for better clarity, formatting, and relevancy:

Director / Sr Director - Clinical Development (Pulmonology), Modena

Role Overview:

This position is responsible for leading and supporting the clinical development of new respiratory drugs, including planning clinical studies and supporting end-to-end drug development in compliance with regulations and company objectives. The role involves engaging with global regulators on respiratory clinical development pathways, reviewing in-licensing respiratory molecules, and participating in ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor clinical sciences respiratory projects, ensuring timely delivery of all milestones.
• Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study start-up and vendor selection processes.
• Guide on subject eligibility, deviations, and protocol-related questions to CRO and site investigators.
• Review blinded efficacy and safety data, including listings, tables, and deviations; escalate issues impacting safety or study integrity.
• Participate in medical monitoring safety meetings and review meeting minutes.
• Review medical coding for adverse events and participate in BDRM reviews.
• Support business development activities, including portfolio management and lifecycle programs.
• Collaborate with internal stakeholders across departments and participate in respiratory forums and meetings.
• Develop projects and evaluate new business opportunities within respiratory, allergy, and inflammation pipelines.

Knowledge and Education:

Qualifications:

• MD or MS degree, with specialization in Internal Medicine and Pulmonary/Critical Care Medicine.

Experience:

• Minimum 18 years of clinical pulmonary experience, with at least 5 years in pharmaceutical clinical development and regulatory interactions.

Skills:

• Drug development expertise
• Scientific advocacy and regulatory engagement

Behavioral Attributes:

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