Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Prato; In loco; EUR 80.000 - 130.000; Tempo pieno

Descrizione del lavoro

Glenmark Pharmaceuticals is seeking a Senior Clinical Development Lead based in Europe or the US, focused on respiratory drug development. This role involves managing clinical projects, collaborating with global regulators, and guiding clinical study design. Ideal candidates should possess a strong background in pulmonary medicine and extensive experience in the pharmaceutical industry.

Competenze

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

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects.
• Contribute to and review key study documents.
• Participate in advisory boards and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Formazione

MD / MS, specialization 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 lead 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 participation in advisory 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 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, 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, addressing or escalating data impacting subject safety or study integrity.
• Participate in internal or joint CRO-sponsor medical monitoring safety meetings and review 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 post-unblinding.
• Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, new initiatives, and lifecycle management programs.
• Build and maintain collaboration with internal stakeholders (Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, Legal, etc.).
• Participate in advisory boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways for faster approvals.
• Develop projects and evaluate new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline, leading strategy and delivery from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

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

Experience:

Minimum 18 years of experience as a practicing pulmonary clinical professional, including at least 5 years in the pharmaceutical industry or clinical project management, with involvement in regulatory interactions for drug development.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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