Executive Director Clinical Development

Role Summary

The 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

Qualifications

• Education: Bachelor‚Äôs degree in a scientific discipline and an advanced degree (e.g., PharmD, RN, PhD, PA, MD). Dermatology-specific experience strongly preferred. Typically requires 10 years industry experience

Skills

• Excellent leadership skills; track record leading successful teams and supervising staff
• Exceptional performance working independently; ability to 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; strong flexibility, pragmatism, and judgment
• Ability to prioritize and manage multiple responsibilities simultaneously
• Exemplary collaboration skills with internal and external stakeholders
• Strong sense of accountability
• Excellent verbal and written communication skills, and interpersonal skills; ability to communicate effectively across functions and organizational levels
• Adherence to highest ethical standards; high integrity
• Ability to receive and provide feedback professionally; strong interpersonal awareness
• Clinical/medical expertise and fluency, e.g., from prior patient care training or experience
• Thorough experience with submissions from pre-clinical through all clinical phases and product launch, including leadership roles and NDA experience; Ex-North America experience preferred
• Foundations in statistics and fluency in dermatologic conditions and dermatology trial assessments and design
• Ability to be a primary organizational representative to external parties (KOLs, scientific meetings, advisory boards)
• Demonstrates pragmatism and ability to produce high-quality results within a matrix environment
• Strengths in change management, conflict resolution, team motivation and building
• Drive for self-improvement; ownership, responsibility, and attention to detail

Education

• Typically requires a Bachelor‚Äôs degree in a scientific discipline and an advanced degree (e.g., PharmD, RN, PhD, PA, MD). Dermatology-specific experience and ~10 years of industry experience preferred.

Additional Requirements

• Travel may be required up to 10% of time