Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Varese; In loco; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a seasoned professional to spearhead the clinical development of innovative respiratory drugs. This pivotal role involves guiding clinical studies, ensuring compliance with regulations, and collaborating with global regulators to facilitate drug approvals. The ideal candidate will possess extensive experience in drug development, strong decision-making abilities, and excellent interpersonal skills. Join a forward-thinking organization that is committed to advancing healthcare through innovative solutions in respiratory, allergy, and inflammation therapies. This is a unique opportunity to make a significant impact in a vital area of medicine.

Competenze

• 18+ years of experience in pulmonary clinical practice with 5+ years in the pharmaceutical industry.
• Expertise in drug development and regulatory interactions.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects ensuring timely delivery.
• Collaborate with internal stakeholders and regulators on development pathways.

Conoscenze

Drug Development expertise

Scientific advocacy with policymakers and regulators

Decision-making skills

Interpersonal skills

Formazione

MD / MS in a relevant medical or scientific field

Specialization in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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 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 participation in advisory boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all milestones.
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, MMPs, and investigator/site lists for vendor selection.
4. Guide on subject eligibility, deviations, and 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 SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
6. Attend internal or joint safety meetings with CROs, review minutes, and ensure safety and compliance.
7. Review blinded medical coding for adverse events, prior and concomitant medications, and medical history, participating in BDRM and providing primary interpretation post-unblinding.
8. Support business development for respiratory programs, including new and lifecycle management projects, and participate in respiratory forums and meetings.
9. Collaborate closely with internal stakeholders across departments and participate in discussions 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, overseeing the strategy from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

• MD / MS in a relevant medical or scientific field.
• Specialization in Internal and Pulmonary/Critical Care Medicine.

Experience:

• Minimum 18 years of experience as a practicing pulmonary clinical professional, with at least 5 years in the pharmaceutical industry or clinical projects involving drug development and regulatory interactions.

Knowledge and Skills (Functional / Technical):

• Drug Development expertise.
• Scientific advocacy with policymakers and regulators.

Behavioral Attributes:

• Strong decision-making and influencing skills.
• Excellent interpersonal skills.