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Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) · 6 days ago

Executive Director Clinical Development

United States

Full-time

Remote

Director/Executive

$240K/yr - $250K/yr

10+ years exp

Arcutis Biotherapeutics, Inc. is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases. The Executive Director of Clinical Development will support the design and execution of the clinical development strategy and direct the implementation of clinical trials.

BiopharmaBiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

Hiring Manager

Kay Dugery

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

Qualification

Clinical development strategyDermatology expertiseClinical trial oversightRegulatory document leadershipStatistical foundationChange managementLeadership skillsTeam collaborationCommunication skillsProblem-solving

Required

Typically requires a Bachelor's degree in a scientific discipline and an advanced degree (eg, PharmD, RN, PhD, PA, MD)

Typically requires 10 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 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

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