Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Asti; 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 new drugs in the respiratory field. This pivotal role involves strategic planning of clinical studies, engaging with global regulators, and ensuring compliance with regulations. The ideal candidate will possess extensive experience in pulmonary clinical practice and drug development, showcasing strong decision-making and interpersonal skills. Join this forward-thinking organization to make a significant impact on drug approvals and enhance patient outcomes. If you are passionate about driving respiratory programs from concept to registration, this opportunity is perfect for you.

Competenze

• At least 18 years of experience as a pulmonary clinical professional.
• Over 5 years in pharmaceutical industry or clinical project management.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and guide CRO staff on medical questions.
• Support business development activities for respiratory programs.

Conoscenze

Drug Development expertise

Scientific advocacy with policymakers and regulators

Strong decision-making skills

Excellent interpersonal skills

Formazione

MD or MS degree

Specialization 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 designed to lead and support the clinical development of new drugs, focusing on innovative approaches to planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and company objectives. It involves discussions with global regulators on respiratory clinical development pathways for facilitating 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 start-up and RFP processes, including CVs, MMPs, and investigator/site lists.
• Guide on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO staff and site investigators.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, escalating issues impacting safety or study integrity.
• Participate in internal or joint CRO-sponsor safety meetings and review minutes.
• Review medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development activities for respiratory programs and portfolio management, including lifecycle management.
• Collaborate closely with internal stakeholders across multiple departments and participate in respiratory forums and meetings.
• Develop projects and evaluate new business opportunities, driving the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education

Qualifications:

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

Experience:

• At least 18 years of experience as a pulmonary clinical professional, with over 5 years in pharmaceutical industry or clinical project management, including regulatory interactions.

Skills:

• Drug Development expertise
• Scientific advocacy with policymakers and regulators

Behavioral Attributes

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