Senior Director Clinical Development

Arcutis Biotherapeutics

1d

About The Position

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

Requirements

• Typically requires a Bachelor’s degree in a scientific discipline and an advanced degree (eg, PharmD, RN, PhD, PA, MD).
• Dermatology-specific experience and expertise is strongly preferred.
• Typically requires 8+ years industry experience.
• 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 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, eg, 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, eg, 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 10% of time worked

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree