Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Development Head to oversee the clinical development of new respiratory drugs. The role involves managing clinical projects, engaging with global regulators, and ensuring compliance with regulations. Ideal candidates will have extensive experience in pulmonary medicine and drug development, with strong leadership and decision-making skills.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical project management.
• Expertise in regulatory interactions for drug development.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study-related documents and provide guidance on medical questions.
• Evaluate new business opportunities and expand the respiratory pipeline.

Conoscenze

Drug development

Scientific advocacy

Decision-making

Interpersonal abilities

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

Pls 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. 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 ad boards and global respiratory meetings.

Job Responsibilities :

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.
2. Contribute to and review key study-related 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 data impacting 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 interpreting efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, including portfolio management, medical affairs, and lifecycle management programs.
9. Collaborate with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and meetings, discussing clinical development pathways with regulators for faster approvals.
11. Evaluate new business opportunities and internal 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 and Pulmonary / Critical Care Medicine.

Experience :

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

Knowledge and Skills :

Expertise in drug development, scientific advocacy with policymakers/regulators.

Behavioral Attributes :

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