Clinical Development Director

Glenmark Pharmaceuticals; Campania; In loco; EUR 100.000 - 180.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks an experienced Clinical Development Lead for respiratory projects. This role emphasizes innovative drug development and regulatory interactions, requiring extensive experience in clinical environments. Candidates should have an MD with extensive experience in pulmonary medicine and a strong advocacy background.

Competenze

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

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery.
• Contribute to and review key study documents such as protocols and informed consents.
• Provide guidance on subject eligibility and deviations, addressing protocols and safety.

Conoscenze

Drug Development

Scientific advocacy with policymakers / regulators

Formazione

MD / MS

MD in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

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. This includes discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals;
• Review and due diligence of in-licensing respiratory molecules;

Presentation in ad boards and global respiratory meetings.

Job Responsibilities :

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables. Responsibilities may include but are not limited to:
• Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs;
• Reviewing CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection;
• Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams;
• Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting review of SAE or SUSAR documents, addressing data impacting subject safety or study integrity;
• Attending internal or joint CRO-sponsor medical monitoring safety meetings and reviewing minutes;
• Reviewing blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM, and interpreting efficacy and safety data post-unblinding;
• Supporting business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs;
• Building and maintaining collaboration with internal stakeholders across departments, participating in ad boards, forums, and discussions with regulators on clinical pathways and approvals;
• Developing projects and evaluating new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.

Knowledge and Education :

Educational Qualifications :

• MD / MS
• MD in Internal and Pulmonary / Critical Care Medicine

Experience :

• Minimum 18 years of experience as a practicing pulmonary clinical professional
• At least 5 years of experience in the pharmaceutical industry or clinical development projects, including regulatory interactions for drug development

Knowledge and Skills (Functional / Technical) :

• Drug Development
• Scientific advocacy with policymakers / regulators

Behavioral Attributes :

• Strong decision-making and influencing skills within a team environment. Good interpersonal skills are essential.