Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development in Pulmonology. This pivotal role involves leading clinical projects, guiding drug development strategies, and engaging with global regulators to ensure compliance and successful drug approval. The ideal candidate will possess extensive experience in pulmonary medicine and a robust background in the pharmaceutical sector. This is an exciting opportunity to influence the future of respiratory therapies and contribute to innovative drug development processes within a collaborative environment.

Competenze

• 18+ years of experience in pulmonary clinical practice, with 5+ years in pharma.
• Expertise in drug development and regulatory interactions.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects to meet milestones.
• Review key study documents and assess CRO capabilities.
• Collaborate with stakeholders and participate in regulatory meetings.

Conoscenze

Drug development processes

Scientific advocacy

Decision-making skills

Interpersonal skills

Formazione

MD / MS with internal medicine specialization

Descrizione del lavoro

Director/ Sr Director - Clinical Development (Pulmonology), Teramo

This position is intended to head and support the clinical development of new drugs, including 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. The role involves discussions with global regulators on respiratory clinical development pathways for drug approval, review and due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones.
2. Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Assess CRO medical monitoring capabilities during study start-up and RFP processes, including reviewing CVs, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and other medical or safety-related questions to CRO MM, site investigators, and study teams.
5. Review blinded efficacy and safety data, including listings, tables, deviations, and support documents related to SAE or SUSARs, addressing issues impacting subject safety or study integrity.
6. Participate in medical monitoring safety meetings and review minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding.
8. Support business development for respiratory programs and portfolio management, including lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings with regulators.
10. Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

• MD / MS, with internal medicine and pulmonary/critical care specialization.

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:

• Drug development processes
• Scientific advocacy with policymakers and regulators

Behavioral Attributes:

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