Director / Sr Director - Clinical Development (Pulmonology)

Buscojobs; Trentino-Alto Adige; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading company is seeking a senior leader to head clinical development for new respiratory drugs, ensuring compliance with regulations and aligning with business goals. This role involves significant interaction with global regulators, management of clinical projects, and collaboration with internal departments. Ideal candidates will have extensive experience in pulmonary medicine and pharmaceutical development.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical development projects.
• Regulatory interaction experience required.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents including protocols and consents.
• Engage with regulators on clinical development pathways.

Conoscenze

Expertise in drug development

Scientific advocacy

Decision-making skills

Interpersonal skills

Formazione

MD / MS in Internal Medicine, Pulmonary, or 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, including the conception of 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. Responsibilities include discussions with global regulators on respiratory clinical development pathways for drug approval facilitation, review & 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 startup and RFP processes, including CVs, MMP, and investigator / site lists for vendor selection.
• 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 documents, addressing or escalating any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review medical 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, and medical affairs, including new and lifecycle management programs.
• Build and maintain collaboration with internal stakeholders across various departments.
• Participate in advisory boards, respiratory forums, and presentations at respiratory meetings.
• Engage with regulators on clinical development pathways for faster approvals.
• Develop projects and evaluate new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline.
• Drive the overall strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education :

Educational Qualifications : MD / MS, with specialization in Internal Medicine, Pulmonary, or 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 development projects, including regulatory interactions.

Knowledge and Skills :

Expertise in drug development, scientific advocacy with policymakers / regulators.

Behavioral Attributes :

Strong decision-making and influencing skills, good interpersonal abilities.

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