Assoc/Sr Director Biomarkers and Companion Diagnostics
(Assoc/Sr) Director, Biomarkers (and Companion Diagnostics)
Responsible for all clinical/translational biomarker (BMx)-related activities across all therapeutic areas at Alpine Immune Sciences (AIS). Conceives, leads, and executes strategies to identify and enrich for responder patient populations, predict patient outcomes, and evaluate pharmacodynamic activity and mechanism of action of AIS therapeutics. Appropriate candidates will further be responsible for the conception, leadership and execution of companion diagnostic (CDx) strategies.
- Develops overall strategies and manages development plans for all biomarker and/or diagnostic tests in support of the lifecycle of all AIS therapies
- Defines program vision, clinical utility, market requirements, and plans required to fulfill development of BMx/CDx’s in alignment with the clinical development plan, and with external partners. Identifies gaps, potential bottlenecks or delays and challenges assumptions, resolves and escalates issues to executive management as needed for each program to ensure programs success while working closely with cross-functional project teams.
- Supports day-to-day operations of BMx/CDx programs, including the following: identifies and selects appropriate internal and/or external partners, manage relationships with partners and their progress against the BMx/CDx plan. Reviews development plans, identifies and resolves any product development issues, oversees budget and drives joint development team meetings.
- May oversee, strategize and/or implement internal pathology and laboratory activities in support of BMx/CDx objectives.
- Develops market requirement documents and global launch strategies, facilitates organizational learning through internal educational programs, representational CDx regulatory strategy for regulatory agencies to support compound regulatory strategy and supports quality team for partner audits
- Represent BMx/CDx strategy at health authority meetings to support overall compound regulatory strategy
· MD and/or PhD or equivalent. 5-10+ yr experience in BMx and/or CDx product development. Experience in oncology and inflammation therapeutic areas strongly preferred. Core competency in immunology or related field also strongly preferred.
· Advanced knowledge of design control, market and product requirements management, and the IVD development process
· Demonstrated track record of success working in a multidisciplinary pharma/diagnostic development team
· Knowledge of diagnostics technology, competitors, and market space. Expertise with flow cytometry will be highly desired.
· Knowledge of the use of biomarkers in pharmaceutical development, especially in companion diagnostic development
· Good knowledge of multiple types of technology platforms (e.g., PCR, immunoassays, immunohistochemistry)
· Knowledge of clinical trials and international regulatory requirements.
· Expert planning and tracking skills, with the ability to capture details and summarize in an integrated cross-functional plan
· Well organized, focused on results, capable of managing multiple projects, excellent time management skills
· Experience-based understanding of diagnostics development process from product concept to launch