Executive Director Clinical Development

Role Summary

Executive Director, Clinical Development supports the design and execution of the Arcutis clinical development strategy and directs the implementation of clinical trials.

Responsibilities

• Leads, develops, supports and implements clinical development program strategy for assigned programs.
• Develops translational strategy and endpoints for early-stage programs, and strategy and clinical endpoints to support late-stage programs through approval and launch.
• Leads activities relating to clinical study design, preparation of protocol synopses, clinical trials oversight, data analyses and written study reports.
• Supports publications and publication strategy.
• Collaborates with external partners and vendors, including Clinical Research Organizations (CROs).
• Leads clinically focused regulatory documents.
• Provides medical input to Competent Authority and Ethics Committee/IRB communications.
• Initiates, develops, and maintains relationships with Key Opinion Leaders (KOLs) and investigators.
• Represents clinical functions to management, as needed
• Other duties that may be assigned, e.g. business development, SOP development.

Education & Licenses And Experience

Typically requires a Bachelor’s degree in a scientific discipline and an advanced degree (e.g., PharmD, RN, PhD, PA, MD). Dermatology-specific experience and expertise is strongly preferred. Typically requires 12+ years industry experience.

Competencies & Skills

• Excellent leadership skills; track record leading successful teams and supervising staff
• Exceptional performance working independently; ability to both function as an independent problem-solver and thrive in a team environment
• Seamless, exemplary performance in a team/matrix setting
• Ability to work in a fast-paced, dynamic environment with very minimal supervision
• Ability to adapt well under pressure; track record of excellent flexibility, pragmatism, and judgment
• Ability to prioritize and manage multiple responsibilities simultaneously
• Exemplary collaboration skills with the ability to work effectively with internal and external stakeholders
• Strong sense of accountability
• Excellent verbal and written communication skills, as well as interpersonal skills; ability to communicate appropriately and effectively to individuals across functions and organization levels
• Adherence to highest ethical standards; consistent high integrity
• Ability to receive and provide feedback in professional, respectful, constructive manner; Strong interpersonal awareness
• Clinical / medical expertise and fluency, e.g., from prior patient care training or experience
• Thorough and deep experience and expertise with submissions from pre-clinical through all clinical phases and product launch, including in leadership roles and with significant NDA experience. Ex-North America experience strongly preferred
• Foundation and fluency in statistics
• Foundation and fluency in dermatologic conditions and dermatology trial assessments and design; subject matter expertise
• Ability to be primary organization representative to key external parties, e.g., KOLs, scientific meetings, advisory boards
• Demonstrates pragmatism, with ability to consistently produce high quality results and navigate quickly and efficiently within matrix environment
• Strengths in change management, conflict resolution, motivating teams, team building, building relationships
• Drive for self-improvement; pride of ownership, takes responsibility, attention to detail
• Travel may be required up to 25% of time worked