Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company seeks a head of clinical development for respiratory programs. The role requires significant experience in drug development, regulatory interactions, and strong leadership skills. The successful candidate will lead projects from candidate evaluation to registration, fostering collaborations with various stakeholders.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical projects involving drug development.

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects.
• Review key study documents and support regulatory interactions.
• Evaluate new business opportunities for respiratory programs.

Conoscenze

Expertise in drug development

Scientific advocacy

Regulatory engagement

Strong decision-making skills

Influencing skills

Interpersonal abilities

Formazione

MD / MS in Internal and Pulmonary / 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, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligned 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 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 for vendor selection.
• 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 blinded SAE or SUSAR documents, addressing or escalating any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review medical meeting minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history; participate in BDRM prior to DBL; interpret efficacy and safety post-unblinding.
• Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, 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 development pathways.
• Evaluate new business opportunities and internal target drug candidates for pipeline expansion in respiratory, allergy, and inflammation.
• Drive strategy and delivery of respiratory programs from candidate evaluation to registration.

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

Experience: Minimum 18 years 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: Expertise in drug development, scientific advocacy, and regulatory engagement.

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