Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Latina; In loco; EUR 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

Glenmark Pharmaceuticals is seeking a seasoned clinical development leader to head innovative drug development projects in respiratory medicine. The role involves managing clinical science projects, engaging with regulators for drug approvals, and supporting portfolio management. Candidates should possess extensive experience in pulmonary medicine and a robust understanding of drug development processes.

Competenze

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

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects.
• Review and contribute to key study-related documents such as protocols and informed consents.
• Provide guidance on subject eligibility and protocol-related questions.
• Support business development for respiratory programs.

Conoscenze

Drug Development

Scientific advocacy

Formazione

MD / MS

MD 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 for facilitating 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 to ensure timely delivery of all milestones.
• Review and contribute to 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 for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, escalating 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 database lock and interpret efficacy and safety data after unblinding.
• Support business development for respiratory programs, portfolio management, and medical affairs in BD and ROW development, including lifecycle management programs.
• Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings, engaging with regulators on development pathways for faster approvals.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical evaluation to registration.

Knowledge and Education :

Educational Qualifications :

• MD / MS
• MD in Internal and Pulmonary / Critical Care Medicine

Experience :

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

Knowledge and Skills (Functional / Technical) :

• Drug Development
• Scientific advocacy with policymakers and regulators

Behavioral Attributes :

The incumbent should excel in decision-making and influencing teams, with strong interpersonal skills.