Clinical Development Director

Glenmark Pharmaceuticals; Liguria; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Development Lead to oversee innovative drug development in respiratory health. Candidates should have extensive experience in pulmonary medicine and pharmaceutical industry interactions. The role involves managing projects, engaging regulators, and contributing to business growth through strategic development and approvals.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical project management.
• Demonstrated expertise in drug development and regulatory interactions.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Engage with regulators on clinical development pathways.
• Support business development for respiratory programs.

Conoscenze

Drug development

Regulatory engagement

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS in Internal Medicine, Pulmonary, or Critical Care Medicine

Descrizione del lavoro

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 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 participation in advisory boards and global respiratory meetings.

Job Responsibilities :

• Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all milestones.
• 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 startup and RFP processes, including CVs, MMPs, and investigator / site lists.
• Provide guidance on subject eligibility, deviations, and other medical or safety-related questions to CRO and site investigators.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, escalating any data 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, and participate in BDRM prior to database lock.
• Support business development activities for respiratory programs and portfolio management, including lifecycle management programs.
• Collaborate with internal stakeholders across various departments and 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 and business growth.
• Drive strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education : MD / MS in Internal Medicine, Pulmonary, or Critical Care Medicine.

Experience : Minimum 18 years as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.

Knowledge and Skills : Expertise in drug development, scientific advocacy, and regulatory engagement.

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

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