Define, develop and control execution of the clinical drug development strategy and the clinical evaluation strategy, together with the scientific leadership of the commercial activities.
- Lead clinical strategic global development plans through the execution and management of the biosimilar clinical trials, assuming the overall management of the clinical trials.
- Contribute to the research and development priorities relating to the biosimilar portfolio worldwide.
- Identify and define new biosimilar and biological development opportunities.
- Act as a medical resource to the company as a whole and particularly to the clinical operations department as for example: project plan, protocol and CRF writing, conduct a medical review of the SAP, tables and listings, adverse events, discussions with investigators, medical monitoring, internal meetings, review/resolve medical issues/questions supporting clinical operations team with recruitment/operational issues, and the Integrated Clinical Study. Also this task also includes: the medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, accepted medications, and general medical-related study issues.
- Create and follow up IDMC, stablish its calendar and tasks during the execution of clinical trials.
- Provide medical expertise in the review of adverse experiences, together with PV department when appropriated, and discuss patient management issues with investigators. Review laboratory alerts, lab reports, and subject profiles as defined within the Safety Medical Monitoring Plan.
- Coordinate and oversee the interim analysis and final analysis/final clinical study report of the clinical trials, and preparation for manuscript preparation and submission,
- Engage Medical Experts and investigators in new clinical trials, identifying partners for future research collaboration.
- Contribute for mAbxience to be recognized as a company expert in the nominated therapeutic areas and provide input into all related product development teams.
- Provide advice across the company on medical, regulatory and clinical matters and activities related to the assigned product portfolio.
- Develop and maintain up-to-date knowledge of the therapy areas by reviewing the literature, discussions with Key Opinion Leaders and key stakeholders, participating in cross functional interactions, attending scientific congresses, etc.
- Prepare the medical and scientific evidence together with a sound business case to communicate the benefits of product portfolio to the market and manage advisory boards effectively.
- Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
- Collaborate in the development of clinical documentation of registration dossiers.
- Co-lead marketing strategy for the development of Brand strategies for Biosimilar products and contributes to the strategic positioning of products across the world.
- Provide valid and timely interpretations of medical data from medical research in the assigned Therapeutic Area and identify appropriate communication strategy for external and internal stakeholders.
- Develop and maintain ongoing relationships with external key opinion leaders (KOLs), healthcare professionals and associations, government authorities, funding bodies, patient organizations and other entities and to provide them medical information relating to the value and correct usage of the biotech products of the Company.
- Develop, attend and represent the Company at appropriate meetings (advisory board meetings, investigator meetings, KOL meetings, CME, mAbxience meetings, etc).
- Manage publications related to the brands. Prepare manuscripts, abstracts, posters as well as other scientific documents.
- Provide medical input to training materials and delivery of events to ensure accuracy of content.
- Work within any given legal framework, mAbxience Ethics and Compliance policies and ensure those around him/her do the same.