Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Alessandria; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a seasoned clinical professional to lead the clinical development of new drugs in the respiratory field. This role involves managing projects, mentoring teams, and ensuring compliance with regulations while driving strategic initiatives. With a focus on collaboration and scientific advocacy, the position offers the opportunity to influence drug development pathways and engage with global regulators. If you have extensive experience in pulmonary medicine and a passion for advancing healthcare, this role could be your next career milestone.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• At least 5 years in the pharmaceutical industry with regulatory interactions.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on subject eligibility.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Job Description:

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 aligning with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals, review and due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.
• Review and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and 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 issues impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor 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 after unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
• Collaborate with internal stakeholders across various departments, participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline and drive program strategy 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 projects in drug development, with 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.