Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company is seeking to fill the role of Clinical Development Head to lead innovative drug development efforts in the respiratory area. The role entails collaborating with global regulators and managing a clinical projects team to ensure the successful delivery of respiratory programs. Candidates should have a strong background in drug development, along with significant experience in clinical project management and regulatory interactions.

Competenze

• Minimum 18 years of experience in clinical practice, over 5 years in pharmaceutical industry.
• Experience in clinical project management, including regulatory interactions.

Mansioni

• Lead and mentor clinical projects ensuring timely milestone delivery.
• Manage and review key study documents and CRO interactions.
• Engage with regulators on clinical development pathways.

Conoscenze

Expertise in drug development

Scientific advocacy

Regulatory engagement

Decision-making

Interpersonal skills

Formazione

MD / MS in Internal Medicine, Pulmonary, or 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, including conception of 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 & 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 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 issues impacting 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, and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
• Build and maintain collaboration with internal stakeholders across various departments.
• Participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways for faster approvals.
• Evaluate new business opportunities or internal target drug candidates for pipeline expansion in respiratory, allergy, and inflammation areas.
• Drive strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications: MD / MS in Internal Medicine, Pulmonary, or 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 project management, including 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 skills.