Amgen Medical Affairs Lead in Breda, Netherlands
Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this:
Medical Affairs Lead
(Cardiovascular / General Medicines)
Amgen develops, produces and manufactures innovative biotechnological medicines available in the Netherlands, for patients in various areas: oncology, hematology, nephrology, cardiology and bone health. As the Medical Affairs Lead CV/GenMed, you will be based at our Dutch Affiliate in Breda.
As the Medical Affairs Lead CV/GenMed, you will be responsible for being the single point of accountability for all Affiliate Therapeutic Area activities and driving the data generation, establishing and communicating the strategy. You will develop goals and tactics, as well as manage resources and budgets and direct our advisors in navigating the products through internal governance and external regulatory portals. Furthermore, you will assist our advisors in interactions and communication with external customers, key organizations and institutions, assess risk and identifying issues, conflicts or gaps across the portfolio and hire, mentor and develop staff and team members.
Medical Degree (MD is a must)
6 or more years of clinical development experience, 4 years of which from a pharmaceutical or biotechnology company
Clinical research experience
Broad and formal leadership experience
In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
Medical knowledge in the relevant therapeutic area
Sound scientific and clinical judgment
Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
Knowledge of Good Clinical Practices (GCP), EMEA regulations and guidelines, and applicable international regulatory requirements
Understanding of new drug commercialization and business practices
Understanding of resourcing and budgeting
Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Demonstrated ability to organize and lead expert Clinical Research Advisory Panels
History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
A Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.
That's why, as a member of the Amgen team, we provide you with valuable opportunities to broaden your experience and maximize your potential. We ensure our staff are equipped to excel today and tomorrow by leveraging state-of-the-art technologies and modern working environments, encouraging open dialogue and professional debate, and collaborating with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.
An online assessment is part of the recruitment process.
For this position we only consider candidates who live in the Netherlands or on a commuting distance from our Breda office, no relocation fee is offered for the position.