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.
Indication Team Lead (Senior Manager Study Management )
What you will do
Let's do this. Let's change the world. In this vital role you
will lead the clinical operational strategies, support development
of CDPs and oversee the planning and operational execution of
multiple early clinical development molecules/programs in phase 0 -
The Indication Team Lead is therapeutically aligned (oncology,
cardiovascular, inflammation, neuroscience, metabolic disorders)
and serves as a consultant and advisor for Global Early Clinical
Development Managers (GECDM) and Early Development Leads (EDL)
within their respective TA. The Indication Team Lead is accountable
for functional management including recruiting and developing a
high-quality Early Development team and supports resource planning
within their respective TA.
- Lead and oversee the development and execution of the
operational strategies for multiple programs within their Early
Development respective TA; Provide strategic operational input to
program CDPs, TPP (target product profiles) and study designs.
- Lead clinical operations teams to ensure effective development
implementation and execution of clinical trials in accordance with
SOPs, GCP and regulatory guidance.
- Accountability at indication level, ensuring strategic
alignment, consistency, and successful risk mitigation; Building
Program/platform/indication expertise with proficiency and
consistency; Cross-functional collaboration with key stakeholders
and Leaders; Identify strategic business requirements to support
their respective indication program needs.
- Participate in KOL engagements; Participates in initiatives to
drive department operational strategy and continuous improvement;
Manages and develops reports
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 proven
leader with these qualifications.
- Doctorate degree and 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
- With 2 years of managerial experience directly managing people
and/or leadership experience leading teams, projects, programs or
directing the allocation of resources
- 10+ years work experience in life sciences or medically related
- 6+ years direct line management experience
- 6+ years of bio-pharmaceutical clinical research experience in
early stage program development obtained working in a biotech,
pharmaceutical or CRO company
- Degree in science related field
- Previous experience in managing clinical programs
- Substantial experience in biotechnology and/or pharmaceutical
clinical research with responsibilities for major aspects of
strategic planning, organization, implementation, and delivery of
- Demonstrated success in managing complex early stage clinical
program activities. Experience in FIH/phase 1 clinical trial
design, regulatory submission package, execution, and reporting of
phase I safety / pharmacology studies
- Demonstrated understanding of translational medicine and the
complexities and recent developments in FIH adaptive design
approaches / clinical pharmacology and the implications for drug
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
- Vast opportunities to learn and move up and across our global
- 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
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.