Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Bari; In loco; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a seasoned professional to head its clinical development for new respiratory drugs. This role involves managing projects, engaging with global regulators, and coordinating cross-departmental collaboration. Ideal candidates will have extensive experience in pulmonary medicine and demonstrated success in drug development processes.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical development.

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects.
• Review and contribute to key study documents.
• Provide guidance on subject eligibility and safety aspects.

Conoscenze

Drug development

Scientific advocacy

Regulatory interactions

Decision-making

Interpersonal abilities

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, involving 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 to facilitate 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, ensuring timely delivery of all milestones.
2. Review and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study startup 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 MM, 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 issues impacting subject safety or study integrity.
6. Attend and review minutes of internal or joint CRO-sponsor medical monitoring safety meetings.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and participate in BDRM prior to DBL, providing primary interpretation post-unblinding.
8. Support business development for respiratory programs and portfolio, including medical affairs and lifecycle management programs.
9. Collaborate closely with internal stakeholders across departments such as Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, and Legal.
10. Participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways for faster approvals.
11. Develop projects and evaluate new business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline and support business growth.
12. Drive the overall 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 as a practicing pulmonary clinical professional with over 5 years in the pharmaceutical industry or clinical development, including regulatory interactions.

Knowledge and Skills: Expertise in drug development, scientific advocacy, and regulatory interactions.

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