Director/ Sr Director - Clinical Development (Respiratory)

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Job Reference: 7450231472016850944337113

Job Views: 1

Posted: 02.05.2025

Expiry Date: 16.06.2025

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, including conception of innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligning them with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals; review & 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 milestones.
• Contribute to and review 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 other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, including listings, tables, deviations, and support review of related safety 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 adverse events, prior/concomitant medications, and medical history; participate in BDRM and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, including new and lifecycle management programs, and build collaborations with internal stakeholders.
• Participate in ad boards, respiratory forums, and regulator discussions on clinical pathways and approval processes.
• Develop projects and evaluate new business opportunities or internal drug candidates for respiratory, allergy, and inflammation pipelines, driving strategy from clinical 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.