Director, Clinical Science

External collaboration:

Leads interactions with with internal experts and external KOLs, Ad Boards for protocol development.

Provides input on CRO / ARO Statement of Work and Budget; represents Clinical Science as the subject matter expert in study team meetings with CRO and ARO

Establishes effective communication between CRO / vendors / ARO

Meets with commercial group regarding new indications for Life Cycle Management. Scientific,

Program related:

Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development strategy;

Contributes to development of program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and react accordingly to new preclinical/clinical data(e.g.; Go/No Go decisions, reprioritization, etc.).

Operational Project Team (OPT) leader; Responsible before the IST for the creation and execution of development strategy for a program.

May potentially act as the Clinical Science functional representative on DAST. Leadership & non-study related activities: Occasional senior management interactions at FIHC, WDC.

Initiates contact w/KOL and prepares material for KOL interactions to support program-based needs.

Involvement with in-licensing and acquisitions on individual due diligence activities.

Supports asset leader in creating a performance-based team culture with clear accountability and a sense of urgency for achieving results both directly and indirectly.

Lead professionals in department specific knowledge, process and procedures.