Focused on patients, committed to success
Transforming biologically active compounds and new chemical entities into safe, effective medicines of the highest quality to safeguard patients’ health is the mission of Merck Serono’s Clinical Development organization.
We are committed to the development of innovative and efficacious therapies for patients with significant unmet medical needs. Our R&D pipeline currently includes approximately 40 projects in clinical development.
The global development structure within Merck Serono is ensured by some 800 medical directors, scientists and administrative personnel located at four main sites in Boston, Darmstadt, Geneva and Tokyo.
Development works hand-in-hand with Research to ensure the safe transition from animal to man of our innovative compounds as they enter the development pipeline. We also support the successful commercialization of our drug products by providing medical expertise at all levels of the Merck Serono organization. We further support our Portfolio Management and Business Development team with strategic alliances and co-development projects with other pharmaceutical and biotechnology partners.
Chief Medical Officer (CMO)
Clinical development provides medical governance within Merck Serono, from first-in-man administration of our compounds through to commercialization. The Chief Medical Officer (CMO) function guarantees the highest ethical standards in all aspects of clinical development, drug safety and regulatory compliance:
- Quality, trust, responsibility and scientific excellence are core elements of our mission.
- The integrity of clinical R&D at Merck Serono is essential to ensure public trust and the respect of customer needs and rights in our clinical study and medical communication programs.
- Merck Serono will foster public trust and confidence in its products by setting adequate Medical and Ethical standards in business practices for developing and during commercialization of its pharmaceutical and medicinal products.
Drug product development is a cross-functional and complex process, coordinated through project teams. Merck Serono’s R&D operational model is designed around the achievement of proof-of-concept, demanding high interaction between functions as well as rapid decision-making. The development organization is an essential and fully integrated component of the project-based organization, representing our two pillars of scientific expertise and operational excellence at project team level.
Global Clinical Operations (GCO)
- Manages all operational aspects of clinical project management including clinical trial leadership and coordination, biostatistics, clinical monitoring, data management, medical writing.
- GCO also looks at constant improvement of our performance, processes and productivity across the portfolio of clinical programs and trials.
Global Regulatory Affairs (GRA)
- Achieves and maintains Marketing Authorizations for global products in the EU, US and Japan and provides optimal support for national Marketing Authorizations in European and International countries.
- Provides regulatory expertise to GCDUs, delivering the latest guidelines and regulations, competitive intelligence and awareness of new regulatory requirements.
- Builds reliable and trustful partnerships and acts as an efficient interface between company and Health Authorities.
Global Clinical Development Units (GCDUs)
- Provide scientific, medical and drug development expertise for the organization. Working closely with Regulatory Affairs, they establish the best development programs to ensure satisfaction of regulatory requirements, data interpretation, preparation of medical content of submission documentation and high quality communication with health authorities.
- Merck Serono’s GCDUs are therapeutically aligned to optimize resources and expertise. Their strategic vision varies based on the maturity of the portfolio and stage of the development pipeline.
