Clinical Development Director

Glenmark Pharmaceuticals; Ozieri; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Director for Clinical Development in respiratory medicine. The role involves overseeing the drug development process, engaging with regulators, leading projects, and mentoring teams. Ideal candidates will have extensive experience in pulmonary medicine and a strong background in clinical drug development and regulatory interactions.

Competenze

• 18+ years in pulmonary clinical practice, including 5+ years in pharma.
• Strong decision-making and interpersonal skills.

Mansioni

• Lead clinical projects, ensuring timely delivery of documents.
• Review CRO capabilities and medical monitoring guidance.
• Engage with internal and external stakeholders on clinical strategies.

Conoscenze

Drug Development

Scientific advocacy

Formazione

MD / MS in Internal Medicine, Pulmonary, or 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, including the conception of innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations, aligning with the company's business objectives. It involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals;
• Review & 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 the 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 startup and RFP processes, including CVs, MMP, and investigator / site lists, as part of vendor selection or final CRO determination;
• 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 blinded SAE or SUSAR documents, addressing or escalating data impacting subject safety or study integrity;
• Participating in 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 before DBL, and interpreting efficacy and safety after unblinding;
• Supporting business development for respiratory programs and portfolio, medical affairs in BD and ROW development, including lifecycle management;
• Building and maintaining collaboration with internal stakeholders across departments and participating in ad boards, forums, and meetings with regulators to discuss clinical development pathways;
• Developing projects and evaluating new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline and drive overall strategy from clinical 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 of experience as a practicing pulmonary clinical professional, including more than 5 years in the pharmaceutical industry or clinical projects related to clinical development, with regulatory interactions for drug development.

Knowledge and Skills (Functional / Technical) :

Drug Development, Scientific advocacy with policymakers / regulators

Behavioral Attributes :

The incumbent should possess good decision-making and influencing skills, along with strong interpersonal skills.

J-18808-Ljbffr