Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; La Spezia; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceuticals company is seeking a Clinical Development Head for respiratory programs, focusing on innovative drug development. The role involves managing clinical projects, engaging with regulators, and ensuring compliance with industry standards while mentoring a team. Ideal candidates will have extensive experience in pulmonary medicine and a solid background in pharmaceuticals.

Competenze

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

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects.
• Review key study documents and CRO medical monitoring capabilities.
• Engage with global regulators and evaluate new business opportunities.

Conoscenze

Drug development expertise

Scientific advocacy

Regulatory knowledge

Formazione

MD / MS with specialization in Internal Medicine, Pulmonary, or 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. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review and due diligence of in-licensing respiratory molecules, and presentations 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 process, 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, listings, tables, deviations, and support review of SAE or SUSAR documents, addressing or escalating issues impacting subject safety or study integrity.
• Participate in internal or joint CRO-sponsor safety meetings and review medical meeting minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs and portfolio, including lifecycle management and new initiatives.
• Collaborate closely with internal stakeholders across departments.
• Participate in ad boards, respiratory forums, and meetings, and engage with regulators on development pathways.
• Evaluate new business opportunities and internal drug candidates to expand the respiratory, allergy, and inflammation pipeline.
• Drive the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education :

• MD / MS with specialization in Internal Medicine, Pulmonary, or Critical Care Medicine.

Experience :

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

Knowledge and Skills : Drug development expertise, scientific advocacy, and regulatory knowledge.

Behavioral Attributes : Strong decision-making, influencing skills, and good interpersonal skills are essential.