Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Novara; Ibrido; EUR 100.000 - 140.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a highly experienced professional to head clinical development for respiratory drugs. The position involves oversight of clinical studies, collaboration with global regulators, and strategic leadership in the development and approval processes. The ideal candidate will have extensive experience in the pharmaceutical industry and a strong foundation in pulmonary medicine.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• At least 5 years in the pharmaceutical industry or clinical drug development.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contribute to key study documents and review CRO capabilities.
• Engage with regulators for clinical development pathways.

Conoscenze

Drug development expertise

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

Pls 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 to facilitate 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 to ensure timely delivery of all deliverables.
• 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.
• Guide 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, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating data impacting safety or integrity.
• Attend and review minutes of internal or joint CRO-sponsor medical monitoring safety meetings.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and participate in BDRM prior to DBL, providing primary interpretation post-unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
• Build and maintain collaboration with internal stakeholders across various departments.
• Participate in ad boards, respiratory forums, and meetings; engage with regulators on clinical development pathways for faster approvals.
• Develop projects and evaluate new business opportunities or internal Target Drug Candidates for pipeline expansion in respiratory, allergy, and inflammation areas.
• Drive overall strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education :

Educational Qualifications : MD / MS, preferably in Internal and Pulmonary / Critical Care Medicine.

Experience :

• Minimum 18 years as a practicing pulmonary clinical professional.
• At least 5 years in the pharmaceutical industry or clinical projects in drug development, including regulatory interactions.

Knowledge and Skills :

• Drug development expertise and scientific advocacy with policymakers/regulators.

Behavioral Attributes :

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