Strategic Development Director (SDD)
Amgen is a full-scale biotechnology company that integrates the nimble and innovative culture of a small biotech with the stability, heritage and experience of a large pharmaceutical company.
Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms - Bispecific T Cell Engagers (BiTE®s), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules - across many targets and more than a dozen tumor types.
In our mission to serve patients, speed is absolutely critical. The Design and Innovation (D&I) group within the Global Clinical Development organization is rapidly expanding our hiring initiatives and 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 D&I works across our oncology pipeline to provide teams with expertise and leadership in the design of innovative clinical development programs and clinical trials. Embedding with product teams during clinical development planning, the SDD brings a holistic knowledge of the end to end clinical drug development process to promote innovative design options that address appropriate clinical questions while optimizing for speed and quality. The SDD partners closely with the Directors of Statistical Innovation (DSI) to develop and promote the adoption of cutting-edge statistical approaches to program and study design to ensure the most efficient development of our oncology pipeline.
Other Key responsibilities include:
- Supports the development and delivery of the Evidence Generation Plan / Clinical Development Plan
- Supports 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
- Identifies value measures, trade-offs, risks, and gaps in development strategy
- Identifies opportunities to apply non-quantitative innovation (e.g., mobile technology, patient voice) to development programs
- Brings the right functions together at the right time and integrates cross-functional input to facilitate end-to-end clinical development
- Objective leader that influences the adoption of novel or innovative approaches
- Liaises with operational design lead to support downstream protocol development and innovative trial execution
Doctorate degree and 4 years of Clinical development experience
Master's degree and 8 years of Clinical development experience
Bachelor's 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
- Proven experience in innovative study design approaches such as adaptive design
- 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 deliverable's
- Excellent verbal and written communication skills
- Builds and maintains relationship for collaboration