Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Parma; In loco; EUR 100.000 - 140.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector seeks an experienced professional to lead clinical development for respiratory drugs. This role involves driving strategies, engaging with regulators, and managing clinical projects while ensuring compliance with industry standards. The ideal candidate will possess strong decision-making abilities and extensive experience in pulmonary medicine and drug development.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or drug development.
• Expertise in drug development and regulatory interactions.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on eligibility.
• Support business development for respiratory programs.

Conoscenze

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, 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 ad boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones.
2. Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
5. Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating any data impacting subject safety or study integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review medical meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM and providing primary interpretation after unblinding.
8. Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, and lifecycle management programs.
9. Build and maintain collaboration with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and meetings, and engage in discussions with regulators on development pathways and faster approvals.
11. Evaluate new business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline.
12. Drive the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications: MD / MS, with specialization in Internal Medicine, Pulmonary, or Critical Care Medicine.

Experience: Minimum 18 years as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects involving drug development and regulatory interactions.

Knowledge and Skills: Expertise in drug development, scientific advocacy, and engagement with policymakers/regulators.

Behavioral Attributes: Strong decision-making and influencing skills, with good interpersonal skills.