Director Clinical Strategic Development
Director Clinical Strategic Development
LSK Biopharma
South San Francisco, CA
Director Clinical Strategic Development (CSD) provides critical expertise and leadership in the design and planning of integrated development plans for multiple disease indications. CSD drives adoption of innovative approaches and strategic thinking in program and study designs. CSD is the engagement lead for decision analysis to support complex development decision making throughout the product development cycle. CSD partners closely with Vice President, Clinical Development (VPCD) when collaborating with Product Team (PT) and Clinical Study Team (CST). CSD reports to VPCD.
Advises Product Strategy and Program/Study Design
- Drives the development and delivery of the Integrated Drug Development Plan (IDDP)
- Manages and obtains input from cross-functional internal and external input into IDDP including Marketing, Regulatory, Clinical Operation and CMC strategies to fully define and document new development potential for LSKB compounds in applicable indications (disease specific).
- Provides innovative development options and strategic, holistic approaches in support of product strategy
- 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
Provides Technical Expertise
- Frames design-related decisions / opportunities
- Supports complex development decision making throughout the product development cycle
- Identifies value measures, trade-offs, risks, and gaps in development strategy
Builds Cross-functional Network
- Brings the right functions together at the right time and integrates cross-functional input to facilitate end-to-end Product development working with PT and CST members and external consultants.
- Objective leader that influences the adoption of a novel or innovative approaches
- Literature review to ensure designs remain aligned to approved strategy once the design is complete by partnering closely with the 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 a professional network of external experts in innovative designs and decision analysis
- Enables innovative and strategic thinking to permeate the broad development organization
Qualifications
MD/PhD 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
- 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
- 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
- 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 a relationship for collaboration
