Director/ Sr Director - Clinical Development (Respiratory)

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

Descrizione del lavoro

An established industry player is seeking a dynamic leader in Clinical Development to spearhead innovative respiratory drug projects. This pivotal role involves mentoring teams, guiding clinical studies, and collaborating with global regulators to ensure compliance and success in drug approval processes. With a focus on expanding the respiratory, allergy, and inflammation pipeline, you will leverage your extensive experience to drive business growth and foster partnerships. Join a forward-thinking company that values scientific excellence and offers a collaborative environment where your expertise will make a significant impact.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and provide guidance to CROs.
• Collaborate with internal stakeholders across departments.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making and influencing skills

Good interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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Director/ Sr Director - Clinical Development (Respiratory), Pavia

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EU work permit required:

Yes

Job Reference:

745023147201685094433713

Job Views:

3

Posted:

06.05.2025

Expiry Date:

20.06.2025

Job Description:

Note: Incumbent can be based anywhere in Europe or the US.

Role Overview:

This position is intended to lead and support the clinical development of new drugs, including planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and aligning with the company's business objectives. It 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 advisory boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.
2. Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study startup and vendor selection processes.
4. Provide guidance on subject eligibility, deviations, and protocol-related questions to CROs and site investigators.
5. Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, addressing any data impacting safety or study integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review minutes.
7. Review blinded medical coding for adverse events and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
8. Support business development for respiratory programs and portfolio management.
9. Collaborate with internal stakeholders across departments and participate in respiratory forums and meetings.
10. Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline and business growth, 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, with over 5 years in the pharmaceutical industry or clinical projects involving drug development and regulatory interactions.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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