Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

Glenmark Pharmaceuticals is seeking a Director/Sr Director for Clinical Development focused on Pulmonology. This pivotal role involves heading clinical studies, ensuring regulatory compliance, and strategic project management within a dynamic environment. Candidates must possess a medical degree and significant experience in drug development and Pulmonology.

Competenze

• Minimum 18 years experience in pulmonary clinical practice, 5+ years in pharmaceutical industry.
• Strong decision-making and interpersonal skills.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Contribute to key study documents, ensuring regulatory compliance.
• Collaborate across departments and facilitate clinical development pathways.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Formazione

MD / MS

MD in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

Director / Sr Director - Clinical Development (Pulmonology)

1 week ago Be among the first 25 applicants

Direct message the job poster from Glenmark Pharmaceuticals

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. Responsibilities include discussions with global regulators on respiratory clinical development pathways, review & 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 milestones.
• 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.
• Provide guidance on subject eligibility, deviations, and 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 SAE or SUSAR documents, addressing any data impacting 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 interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
• Collaborate with internal stakeholders across departments and participate in ad boards, forums, and regulatory discussions to facilitate clinical development pathways and approvals.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate 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, with over 5 years in the pharmaceutical industry or clinical projects in drug development, including regulatory interactions.

Knowledge and Skills (Functional / Technical) :

• Drug Development
• Scientific advocacy with policymakers / regulators

Behavioral Attributes :

• Strong decision-making and influencing skills.
• Good interpersonal skills.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research
• Pharmaceutical Manufacturing and Research Services

J-18808-Ljbffr