Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company is seeking a senior professional to head clinical development for respiratory drugs. The role involves managing projects, engaging with regulators, and ensuring compliance with drug development regulations. Candidates should have extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical projects.
• Expertise in drug development and scientific advocacy.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and CRO medical monitoring capabilities.
• Collaborate with internal stakeholders across departments.

Conoscenze

Drug Development

Scientific Advocacy

Regulatory Interactions

Decision-Making

Interpersonal Skills

Formazione

MD / MS in Internal 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 aligned 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 :

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring 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. Guide 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 data impacting safety or integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
9. Collaborate 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.
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 and Pulmonary / Critical Care Medicine.

Experience :

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

Knowledge and Skills (Functional / Technical) :

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

Behavioral Attributes :

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