Description
The Executive Director, Clinical Development supports the design and execution of the Arcutis clinical development strategy and directs the implementation of clinical trials.
Roles & 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, eg, business development, SOP development.
Job Complexity, Discretion and Interaction
Provides both strategic and hands-on clinical development direction for multiple clinical programs. Erroneous decisions could have a serious impact on the success of the Clinical Development function and Arcutis. Interacts internally with all levels of staff, including the company's leadership team, requiring negotiation of difficult matters. Interacts with external people and organizations, eg, regulatory bodies, KOLs, professional societies, and patient groups. Influences policies and strategic direction both internally and externally.
Education & Licenses and Experience
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 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, 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 25% of time worked
Why Join Us?
Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exciting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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Equal Opportunity Employer, including disability/protected veterans
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