Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Lodi; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a seasoned professional to lead clinical development in respiratory drug projects. This pivotal role involves strategizing innovative clinical studies, engaging with global regulators, and ensuring compliance with all regulations. You will mentor teams, review critical study documents, and support business development initiatives. If you have extensive experience in the pharmaceutical sector and a passion for advancing respiratory therapies, this opportunity is your chance to make a significant impact in the field.

Competenze

• 18+ years of experience in pulmonary clinical practice and drug development.
• Strong background in regulatory interactions and clinical project management.

Mansioni

• Lead and mentor Clinical Sciences projects for timely delivery of milestones.
• Review key study documents and provide guidance on medical and safety questions.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making skills

Interpersonal skills

Formazione

MD / MS

MD in Internal Medicine 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, involving 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 includes discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals, review and due diligence of in-licensing respiratory molecules, and presentations 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 reviewing 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 process, including CVs, MMPs, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs, including lifecycle management and new programs.
• Collaborate with internal stakeholders across departments, participate in ad boards, forums, and meetings, and engage with regulators on clinical development pathways for faster approvals.
• 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 Medicine 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 in drug development, including regulatory interactions.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Strong decision-making and influencing skills, with good interpersonal skills.