Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Plasencia; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a clinical development leader to drive innovative drug development in respiratory medicine. This role involves managing clinical projects, engaging with global regulators, and ensuring compliance with regulations while aligning with business objectives. The successful candidate will have extensive experience in pulmonary medicine and drug development, showcasing strong decision-making and interpersonal skills. Join a forward-thinking organization that values collaboration and innovation in expanding its respiratory pipeline and enhancing patient outcomes.

Competenze

• Minimum 18 years of experience in pulmonary clinical practice, with over 5 years in drug development.
• Strong decision-making and influencing skills are essential.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects to ensure timely delivery.
• Review key study documents and provide guidance on medical and safety questions.

Conoscenze

Drug Development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS

MD in Internal and 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 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 aligning with the company's business objectives. The role 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 ad boards and global respiratory meetings.

Job Responsibilities

1. Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones and deliverables.
2. Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists, for vendor selection or final CRO determination.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
5. Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating issues impacting safety or study integrity.
6. Attend internal and joint CRO-sponsor safety meetings and review meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM prior to database lock, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, portfolio management, and medical affairs in BD and ROW development, including new and lifecycle management programs.
9. Maintain collaboration with internal stakeholders across various departments and participate in ad boards, respiratory forums, and meetings. Engage with regulators on development pathways and approval processes.
10. 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

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 involving drug development and regulatory interactions.

Knowledge and Skills (Functional / Technical)

• Drug Development
• Scientific advocacy with policymakers and regulators

Behavioral Attributes

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