Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Trentino-Alto Adige; In loco; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Clinical Development Lead to spearhead drug development initiatives in respiratory medicine. This role involves strategic planning, regulatory discussions, and collaboration with internal teams to ensure successful drug approvals. The ideal candidate will leverage extensive clinical experience to guide projects and mentor teams, while also engaging with global regulators to navigate complex development pathways. Join this dynamic environment where your expertise will drive the future of respiratory healthcare and contribute to groundbreaking advancements in medicine.

Competenze

• 18+ years as a pulmonary clinical professional, with 5+ years in the pharmaceutical industry.
• Experience with regulatory interactions for drug development.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects, ensuring timely deliverables.
• Review key study documents and provide guidance on medical and safety questions.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making

Interpersonal skills

Formazione

MD / MS

MD in Internal Medicine or 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 leads and supports 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. Responsibilities include 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 ad 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 start-up and RFP processes, including CRO CVs, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR related documents, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor medical monitoring safety meetings and review meeting minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM prior to database lock, and interpret efficacy and safety data after unblinding.
• Support business development for respiratory programs, portfolio, medical affairs, and lifecycle management programs in BD and ROW.
• Collaborate closely with internal stakeholders across various departments, participate in ad boards and respiratory forums, and engage 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 candidate evaluation to registration.

Knowledge and Education

Qualifications:

• MD / MS
• MD in Internal Medicine or Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years as a practicing pulmonary clinical professional, with at least 5 years in the pharmaceutical industry or clinical projects involving regulatory interactions for drug development.

Knowledge and Skills

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes

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