Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Pistoia; In loco; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a seasoned clinical development leader to spearhead the advancement of new drugs in respiratory health. This pivotal role involves strategic oversight of clinical studies, regulatory interactions, and collaboration with global stakeholders to ensure successful drug approval. The ideal candidate will bring extensive experience in pulmonary medicine and a robust understanding of drug development processes. Join this dynamic team and contribute to groundbreaking advancements in respiratory therapies, driving impactful change in patient care and health outcomes.

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 for timely delivery.
• Review key study documents and provide guidance on medical questions.
• Collaborate with internal stakeholders and engage with regulators.

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 aligning with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways for drug approval facilitation, 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 to ensure timely delivery of all objectives.
• 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.
• 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 or escalating data impacting subject safety or study integrity.
• Participate in medical monitoring safety meetings and review meeting 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 management, and medical affairs in BD and ROW development, including lifecycle management programs.
• Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings, engaging with regulators on development 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 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 related to clinical development and regulatory interactions.

Knowledge and Skills (Functional / Technical)

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes

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