Strategic Clinical Development Director (Open to remote)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Strategic Clinical Development DirectorLive
What you will do
Lets do this. Lets change the world. In our mission to serve patients, speed is absolutely critical. The Strategic Development Organization (SDO) within the Center for Design and Analysis in the Global Clinical Development organization is rapidly expanding our hiring initiatives and we are excited to unite with the most passionate and brilliant clinical development talents who want to join our team working toward our mission of advancing high potential programs for cancer patients around the world.
The Strategic Development Director (SDD) within the SDO works across our pipeline to provide teams with expertise and leadership in the design of innovative clinical development programs and clinical trials. Embedding with clinical teams during product development planning, the SDD brings a holistic knowledge of the end-to-end clinical development process. Combining experience in the scientific design of clinical programs and studies, clinical data, regulatory science and product commercialization with decision science-based approaches the SDD promotes the generation of innovative product development strategies and study designs. The SDD partners closely with the data and 'omics roles in the SDO, as well as Directors of Statistical Innovation within the Design and Innovation group, to develop and promote the adoption of cutting-edge, data-informed clinical design approaches to ensure the most appropriate and efficient development of our pipeline.
Other key responsibilities include:
- Support the development and delivery of key components of the Evidence Generation Plan/Clinical Development Plan
- Support complex development decision making throughout product development cycle. The SDD leads teams through a qualitative approach to create strategic development options through framing, issue raising and classification, decision hierarchy, and strategy table generation
- Liaise with other Strategic Development roles and statistical innovators to support strategic option generation and innovative trial design
- Identify value measures, trade-offs, risks, and gaps in development strategy
- Identify opportunities to apply non-quantitative innovation (eg, mobile technology, patient voice) to development programs
- Bring the right functions together at the right time and integrate cross-functional input to facilitate endto-end clinical development
- Objective leader that influences the adoption of novel or innovative approaches
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 [type of person] with these qualifications.
End-to-end clinical development knowledge and experience
Clinical development strategy development experience
- Doctorate degree and 4 years of clinical development experience
- OR Masters degree and 8 years of clinical development experience
- OR Bachelors degree and 10 years of clinical development experience
- Strong facilitation, influencing, and negotiation skills
- 10 years of clinical research design experience in a clinical setting and in executing clinical trials
- End-to-end product development knowledge and experience
- Demonstrated experience in innovative study design approaches such as adaptive design
- Appreciation of current regulatory and commercial landscape
- Ability to integrate and synthesize cross-functional input as it relates to evidence generation and apply decision science framework to facilitate data-driven decision making
- Understands and can communicate implications of cross-functional inputs to teams
- Experience with innovative development approaches and understanding of how/when to apply them (fit for purpose approach)
- Exhibits strategic and holistic approach to product development and is forward thinking
- Understands how data and analytics can inform study design, development options, and knows where/when to apply them
- Contextualizes data and objectives for analytical partners
- Leadership capabilities to guide and motivate others and drive deliverables
- Excellent verbal and written communication skills
- Builds and maintains relationship for collaboration
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.comEqual 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.
Join UsIf 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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.