Amgen Senior Manager, Clinical Study Management in Thousand Oaks, California
Biosimilars are an important development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients! Quality biosimilar development requires a new paradigm, integrating all the science and experience at Amgen developing biologics as well as our quality manufacturing while creatively and rapidly executing a efficient method for study execution to demonstrate comparability to the originator product.
The Sr. Manager Study Management will lead Biosimilars study execution within a full-service CRO model.
Coordinate and lead all aspects of the planning, management, execution, and reporting of trials in partnership with CROs
Ensure execution of assigned clinical trials with high quality, on time and on budget
Management of study timelines, oversight of CRO study team performance, scopes of work, and budget
Identify and resolve functional issues and regional issues associated with study with CRO partners
Ensuring implementation of studies in accordance with SOPs and ICH/GCP guidelines
Chip in to the authoring and review of study documents and plans (protocols, ICFs)
Collaborate with the global study team and CRO partners to ensure operational excellence and efficiencies
Communicate program status and issues
Integration and oversight of Amgen and CRO processes for efficient study execution and quality delivery
Support of strategic plan and regulatory interactions including IND/BLA applications and regulatory inspections
Leading initiatives and process improvement work streams
Domestic and international travel up to 10% as needed
Doctorate degree with 2 years of clinical experience; OR Master’s degree and 6 years of clinical experience; OR Bachelor’s degree and 8 years of clinical experience; OR Associate’s degree and 10 years of clinical experience; OR High school diploma / GED and 12 years of clinical experience
Master’s degree in sciences
7+ years work experience in life sciences or medically related field, including 5 + years of biopharmaceutical clinical research experience acquired working on industry-sponsored, global clinical trials in biotech, pharmaceutical or CRO company
Excellent cross-functional coordination within Amgen and with CRO partner(s)
Experience in leading cross-functional teams
Experience in oversight of outside vendors (CRO, central labs, etc.) under a fully outsourced environment
Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines
Demonstrated understanding of Biopharmaceutical/Healthcare Compliance
Knowledge to present and evaluate strategies for clinical development and critically evaluate outside specialist or vendor advice
High level of personal accountability, flexible
Highly responsive with ability to multi-task
Ability to anticipate and resolve problems
Experience writing and presenting scientific and clinical issues
Excellent interpersonal and organizational skills
Excellent oral and written communication skills
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.