Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Palermo; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Glenmark Pharmaceuticals seeks a lead for Clinical Sciences to oversee the development of respiratory drugs. This role requires strong experience in clinical pulmonary practice, overseeing drug development, and collaboration with regulators. The chosen candidate will mentor teams, ensuring timely delivery of projects, while navigating regulatory requirements for new drug approvals. Ideal for those with a proven track record in the pharmaceutical industry.

Competenze

• Expertise in drug development and regulatory engagements.
• Minimum 18 years in clinical pulmonary practice.
• Over 5 years in pharmaceutical industry or clinical development, with regulatory interactions.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contribute to review and due diligence of clinical documents.
• Engage with regulators on development pathways for drug approvals.

Conoscenze

Drug development

Regulatory engagement

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS with specialization 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, including conception of 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 ensuring timely delivery of all deliverables.
• Contribute to and review key study-related 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 any data impacting safety or integrity.
• Attend medical monitoring safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and participate in BDRM prior to DBL, providing primary interpretation after unblinding.
• Support business development for respiratory programs and portfolio, including lifecycle management and new program evaluation.
• Collaborate with internal stakeholders across departments.
• Participate in ad boards, respiratory forums, and meetings, engaging with regulators on development pathways.
• Lead project development from candidate evaluation to registration, driving strategy and delivery.

Knowledge and Education :

MD / MS with specialization in Internal and Pulmonary / Critical Care Medicine.

Experience :

Minimum 18 years in clinical pulmonary practice, with over 5 years in the pharmaceutical industry or clinical development projects, 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 are essential.