Operational Design Lead
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
Operational Design Lead
What you will do
Let's do this. Let's change the world. In this vital role you will be driving delivery of an operationally integrated study design and protocol and lead study teams through the protocol design process and operational plan development, including Amgen required documents; Risk Assessment Categorization Tool (RACT), Global Study Operational Plan (GSOP), Data Elements Planning Tool (DEPT).
- Partner with the Strategic Development Director (SDD) role within the Design and Innovation team, to ensure timely hand-off of key study design elements (e.g., objectives, endpoints, eligibility criteria, schema) to trigger integrated operational protocol development
- Serves as a project manager and facilitator for the study design, protocol development, and operational plan development process for protocols operationalized by Global Clinical Program Management (GCPM)
- Understands and advise on operational study design, study start up timelines and triggers points for downstream activities, critical path implications
- Partners closely with Clinical Program Manager, Clinical Research Medical Director (CRMD) and Global Regulatory Writing (GRW) to align on process, design and results
- Partners with multiple cross-functional roles to ensure clarity of responsibilities and timely engagement and input
- Establishes and agrees with Clinical Program Manager and Clinical Study Planner (CSP) on detailed study design development timeline aligned with overall study timeline
- Schedules working sessions / ad-hoc meetings, and develops agendas, action items, minutes, etc.
- Facilitates necessary study protocol design decisions to inform the operational plan and ensures that operational considerations are included in protocol development (highlighting downstream impact of design decisions)
- Leadership of study specific RACT, GSOP and DEPT processes within study design framework as well as ensuring appropriate development of Integrated Quality Risk Management Plans (IQRMP)
- Surfaces disconfirming information during the design process to ensure creation of a fit-for-purpose and efficient study design, considering operational and risk mitigations
- Identifies need for missing cross-functional input, information or data and facilitates effort to acquire it
- Partners closely with Strategic Development Director to ensure study design is aligned with strategy and key design decisions are retained
- Enables review and discussion of operational modeling data within the study design process
- Provides insights for certain triggers and trade-offs (e.g., cost and time)
- Advises study placement discussion with cost, speed, and quality inputs from relevant team members and patient engagement, recruitment and retention strategies
- Defines and contributes to the continuous improvement of study design, feasibility and planning processes and study operational execution.
- Provide feedback and contributes to continuous improvement of GSOP, CT-RACT and DEPT processes to respective BPOs
- Identifies and demonstrates external knowledge of industry best practices, processes and new trends
- Develop industry leading operational capabilities
- Contribute to functional goal setting in Global Development Operations
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The clinical professional we seek is a strong project manager with these qualifications.
- Doctorate degree and 2 years of clinical research experience OR
- Master's degree and 6 years of clinical research experience OR
- Bachelor's degree and 8 years of clinical research experience
- 9+ years work experience in life sciences or medically related field, including 6+ years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
- Experience at or oversight of outside clinical research vendors (CRO's, central labs, imaging vendors, etc.)
- A strong background in clinical operations with clinical trial execution experience
- Proven delivery of results and team leadership
- An understanding of the trade-offs between optimal study design to meet strategic objectives, operational efficiency and cost
- A project management skill set, with the ability to facilitate a team discussion to reach decisions and clear outputs
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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.