Strategic Development Director (SDD)

Employer
Amgen
Location
Thousand Oaks, California
Posted
Aug 18, 2018
Ref
R-56270
Required Education
Doctorate/PHD/MD
Position Type
Full time

Strategic Development Director (SDD) provides critical expertise and leadership in the design and planning of innovative development programs and clinical trials. SDD drives adoption of innovative approaches and strategic thinking in program and study designs. SDD is the engagement lead for decision analysis to support complex development decision making throughout the product development cycle. SDD partners closely with Director, Statistical Innovation (DSI) when collaborating with Product Team (PT), EGT and Clinical Study Team (CST).

Advises Product Strategy and Program/Study Design

  • Promotes innovative design options and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol / program design and balance speed, quality, and cost
  • Supports the development and delivery of the EGP
  • Provides innovative development options and strategic, holistic approaches in support of product strategy

Provides Technical Expertise

  • Frames design-related decisions / opportunities
  • Supports complex development decision making throughout product development cycle
  • 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 EGTs

Builds Cross-functional Network

  • Brings the right functions together at the right time and integrates cross-functional input to facilitate end -to-end EGP development working with EGTs and study teams
  • Serves as a product network (extended / agenda driven) EGT member
  • Partners with DSI when work with PT/EGT/CST
  • Objective leader that influences the adoption of novel or innovative approaches
  • Literature review to ensure designs remain aligned to approved EGP strategy once design is complete by partnering closely with study team
  • Liaises with operational design lead to support downstream protocol development and innovative trial execution

Promotes the advancement of innovative designs and analysis methods

  • Builds professional network with external experts in innovative designs and decision analysis
  • Enables innovative and strategic thinking to permeate the broad development organization

Basic Qualifications

Doctorate degree and 4 years of Clinical experience
OR
Master's degree and 8 years of Clinical experience
OR
Bachelor's degree and 10 years of Clinical experience

Preferred Qualifications

  • Proven experience in innovative study design approaches such as adaptive design
  • 10 years of clinical research design experience in a clinical and/or academic setting and in executing clinical trials
  • End-to-end product development knowledge and experience
  • 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
  • Strong facilitation, influencing, and negotiation skills
  • Excellent verbal and written communication skills
  • Builds and maintains relationship for collaboration