Director/ Sr Director - Clinical Development (Respiratory)

Buscojobs; Campania; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a dynamic leader to head clinical development for innovative drug approaches. This role involves managing respiratory projects, engaging with global regulators, and ensuring compliance with all regulations. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in drug development. You will collaborate with various stakeholders and contribute to the strategic direction of the respiratory pipeline. If you have a passion for advancing medical science and thrive in a collaborative environment, this opportunity is perfect for you.

Competenze

• Minimum 18 years of experience in pulmonary clinical practice.
• At least 5 years in the pharmaceutical industry with regulatory interactions.

Mansioni

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

Conoscenze

Drug Development

Scientific advocacy with policymakers / regulators

Decision-making

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

Pls 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 aligned with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review & 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 milestones. Responsibilities may include but are not limited to:
• Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Reviewing CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
• Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
• Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting blinded SAE or SUSAR documents, addressing or escalating data impacting subject safety or study integrity.
• Attending internal or joint CRO-sponsor safety meetings and reviewing minutes.
• Reviewing blinded medical coding for adverse events, medications, and medical history, participating in BDRM prior to database lock, and interpreting efficacy and safety data post-unblinding.
• Supporting business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
• Building and maintaining collaboration with internal stakeholders across various departments. Participating in ad boards, respiratory forums, and meetings. Engaging in discussions with regulators on clinical pathways and approval processes.
• Developing projects and evaluating new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy and delivery 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, including at least 5 years in the pharmaceutical industry or clinical development, with regulatory interactions for drug development.

Knowledge and Skills (Functional / Technical) :

• Drug Development
• Scientific advocacy with policymakers / regulators

Behavioral Attributes :

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