Career Category
Clinical DevelopmentJob Description
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.
[BeiGene Collaboration Clinical Lead]
Live
What you will do
Amgen and BeiGene have entered into a strategic collaboration; to advance and commercialise a select set of Amgen's innovative oncology products, jointly fighting cancer and meeting the needs of patients in China. This role will be essential to the success of the collaboration; providing sponsor oversight, strategic leadership and enabling day-to-day operational delivery of clinical trials within the collaboration.
- Reporting to JAPAC Development Head for local activity and GCPM Therapeutic Area Head (TAH) for operational delivery
- Sponsor oversight of clinical trial delivery by BeiGene in China in accordance with GCP requirements and local China regulations
- Relationship owner between Amgen and BeiGene in context of ABC CTE (including key medical roles)
- Drive continuous improvement and evolve the operating model as appropriate
- Collaboration oversight and governance (including risk management, metrics, Key Performance Indicators etc.)
- Ensure that external factors are considered in the ABC (including country regulatory and compliance)
- Co-chair of the joint functional team and member of the joint operational team and provide input to the BMT as required
- Management of clinical trial resourcing activities and reconciliation
- Ensure collaboration training development & document updates are maintained and compliant
- Oversight of integration of clinical trial system updates within ABC model
- Line management responsibilities
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.
Basic Qualifications
•BA/BS/BSc or RN•5+ years China work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)•5+ years China clinical operations experience and/or regional study management experience•Experience at, or oversight of, outside clinical research vendors (Clinical research organisations, central labs, imaging vendors, etc.)•Previous management experience of direct reports, including management level staffPreferred Qualifications
•PhD, PharmD, Master’s Degree•Experience at, or oversight of, strategic collaboration projects with industry peersKnowledge
•Basic scientific/medical/clinical knowledge•China specific biopharmaceutical industry knowledge•Cross-cultural knowledge•Finance and budgeting•Familiarity with speed, productivity, cost and quality metrics•Knowledge of China regulatory requirements and guidelines for conducting clinical research and safety monitoring / reporting•Project and Program management including oversight of study deliverables, budgets and timelines•Relevant operational expertise•Understanding of resource management and organizational capacity management•Experience in developing goals and training plans to maximize talent and career development of staff•Ability to network and build relationships to maximize organizational and functional capabilities•Experience in leading organizations through change
Thrive
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
Apply now
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.
careers.amgen.com
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.
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