Medical Director

4 weeks ago

Maryland, United States Agomab Therapeutics Full time

Medical Director

Department: Clinical Development

Employment Type: Full Time

Location: Agomab Antwerp

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. 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, Pharmacovigilence, and Clinical Research Organizations (CROs).

Key Responsibilities
  • Contribute to the elaboration of clinical development plans for the company’s products, in keeping with the corporate strategy;
  • Contribute to the development of product registration strategies and lead interactions with regulatory authorities;
  • Design, author and develop clinical study protocols (Phases 1 to 3) from a concept sheet to a full protocol; 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, produce relevant training materials, and represent clinical development in 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 ethical committees, in collaboration with regulatory affairs and/or 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;
  • Identify and establish relationships with leading key opinion leaders (KOLs), including organizing and moderating KOL meetings and Advisory Boards;
  • 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;
  • Hands on experience and knowledge of the drug development process from Phases 1 to 3, trial management and vendor oversight, safety reporting, MedDRA and WHODrug dictionaries, study methodology, data reviews, statistical analysis plans and local and global clinical trial regulations;
  • Clinical experience in hepatology, gastroenterology, or respiratory medicine would be an asset;
  • Strong scientific knowledge in the fields of inflammation, fibrogenesis, 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 communicate the Company’s R&D activities to the financial community and Pharma partners;
  • Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet stretch goals;
  • Positive approach to work and ability to motivate team members to meet timelines and project goals is required;
  • Ability to develop strong relationships with study investigators and key opinion leaders within therapeutic area;
  • High integrity and the ability to bring out the best in others, intellectually and interpersonally.
Benefits
  • The opportunity to develop pioneering science in a young biotech company
  • Challenging and innovative work environment as part of a driven team
  • Flexibility and responsibility based in Antwerp with remote working options that can be tailored for you
  • Competitive salary and benefits
  • An agile and fast paced environment
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