Senior Medical Director Respiratory

Department: Clinical Development

Employment Type: Full Time

Location: Agomab All Sites

Description

Reporting to the Chief Medical Officer (CMO), the Medical Director (MD) will lead clinical development activities for new drug candidates across multiple therapeutic areas and indications with a focus on respiratory disorders. The MD will assume a hands-on role in the design and oversight of clinical trials, in close partnership Clinical Strategy and Operations, Regulatory Affairs, Pharmacovigilance, Key Opinion Leaders (KOLs), and Clinical Research Organizations (CROs).

Key Responsibilities

• Contribute to the elaboration of clinical development plans for the company’s respiratory products, in keeping with the corporate strategy;
• Contribute to the development of product registration strategies and lead interactions with regulatory authorities;
• Identify and secure the participation of KOLs in the field of respiratory medicine. Prepare and lead clinical advisory board meetings.
• Lead the elaboration of clinical study designs (Phases 1 to 3), develop concept sheets and oversee the writing of full study protocols; lead the review and finalization process with clinical operations, medical writing, regulatory affairs, clinical pharmacology, and other key cross-functional contributors.
• Oversee and participate to protocol training, development of training materials, and represent clinical development at Investigator meetings.
• Contribute to study processes and deliverables and participate in development of informed consent forms (ICF), case report forms (CRF), safety management plans, medical monitoring plans, statistical analysis plans (SAP) and clinical study reports (CSR).
• Lead the development of clinical responses to protocol questions by healthy authorities, independent review boards and Ethics committees / Institutional Review boards, in collaboration with regulatory affairs and clinical operations.
• Review patient profiles and study level data; review coding of adverse events (AEs), concomitant medications and protocol deviations.
• In close collaboration with clinical operations, data management, biometrics and CRO, participate in all reviews and procedures required for database lock.
• Review study data outputs to provide the most comprehensive clinical interpretation, for interim and final study reporting; develop topline study reports in collaboration with biometrics and relevant stakeholders (e.g., clinical pharmacology, translational sciences, etc.).
• Participate in the development and implementation of scientific communication and publication strategies for ongoing and completed studies.
• Support pharmacovigilance process; review individual data with Serious Adverse Events (SAEs) and important medical events; author and/or review all safety narratives and related regulatory reports (CIOMS, MedWatch)
• Support the timely execution of all clinical trials and the generation of high-quality clinical data according to predefined timelines and budget.
• Oversee the safety of subjects participating into clinical trials sponsored by the Company, and ensure full compliance with applicable rules and regulations overseeing pharmacovigilance
• Provide medical and scientific expertise into Agomab’s Discovery and Preclinical Development programs.
• Contribute relevant sections of Investigational New Drug (IND) dossiers, Investigator’s Brochures (IB), DSURs and other regulatory documents.

 

Skills, Knowledge and Expertise

• M.D. or M.D.-PhD degree with clinical research and 5+ years of experience in clinical development in the pharmaceutical or biotech industry, with 3+ years at the medical director level.
• Clinical experience as respiratory physician and/or proven track record in developing respiratory products is required.
• Experience with inhaled therapies would be an asset.
• Clinical experience and/or drug development record in additional therapeutic areas including hepatology or gastroenterology would be an asset.
• Hands on experience and knowledge of the drug development process from Phases 1 to 3.
• Strong scientific knowledge in the fields of inflammation, fibrosis, and tissue repair/regeneration.
• Demonstrated ability to develop and implement global clinical development strategies involving key opinion leaders and according to the relevant regulatory framework.
• Experience with regulatory activities in US and EU, as well as direct experience with IND/CTA filings, special designation submission (Orphan Drug Designation, Fast Track, PRIME, Breakthrough designations) is a plus.
• Excellent oral and written communications skills and ability to effectively comm