Director/ Sr Director - Clinical Development (Pulmonology)

Buscojobs; Umbria; In loco; EUR 120.000 - 200.000; Tempo pieno

Descrizione del lavoro

A prominent company in the pharmaceutical industry seeks a senior leader for clinical development, focusing on innovative respiratory programs. The ideal candidate has extensive experience in pulmonary medicine and regulatory processes, with strong project management skills to oversee drug development from inception to approval.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• At least 5 years in pharmaceutical industry or clinical project management.

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects.
• Review and contribute to key study documents and assess CRO capabilities.
• Provide guidance on subject eligibility and review blinded safety data.

Conoscenze

Drug Development

Scientific advocacy with policymakers and regulators

Formazione

MD / MS

MD in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

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 and 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.
• Review and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study startup and RFP processes, including review of CVs, MMP, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and 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 SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Participate in internal and joint CRO-sponsor medical safety meetings and review meeting minutes.
• Oversee blinded medical coding for adverse events and medications, participate in BDRM prior to database lock, and interpret efficacy and safety data post-unblinding.
• Support business development activities for respiratory programs, including portfolio management, medical affairs, and lifecycle management programs.
• Build collaborative relationships with internal stakeholders across departments and participate in ad boards, respiratory forums, and regulatory discussions.
• Drive project development, evaluate new business opportunities, and oversee the strategy and delivery of respiratory programs 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 project management involving 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.