Director – Clinical Operations

Director – Clinical Operations

Requirements

• BS or equivalent advanced degree.
• 15+ years of experience in drug development with recent experience in oncology drug development and autologous cell therapy.
• 10+ years of experience in managing complex teams.
• Proven track record of managing complex cell therapy studies, autologous cell therapy experience is required.
• Proven track record of managing complex early phase clinical trials in cell therapy or immuno-oncology.
• Experience managing direct reports
• Knowledge of advanced information technology to facilitate complex clinical monitoring.
• Excellent understanding of regulatory processes and clinical development.
• Excellent organizational skills and ability to prioritize and deliver results.
• Excellent communication and influencing skills and proven ability to lead in a matrix environment.
• Creative and innovative leadership with a sharp objective intellect and experience balancing big picture thinking with detailed analysis.

Responsibilities

• Manage all operational and strategic operational aspects of assigned programs
• Give input to Development activities for assigned studies
• Contribute to resource strategy for assigned programs
• Collaborate in the development of the target product profiles (TPPs) and CDPs by generating scenario plans, high-level forecasting of timelines, assessing global program-level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies
• Handle unique challenges and decisions that have an impact on programs and disease area.
• Develop and communicate budget, resource, risks and timelines to review bodies
• Operate at strategic level including input into risk management plans, value assessment and therapeutic area/indication expertise. Long-range planning horizon is typically 2 or more years
• Provide program leadership with oversight, guidance, and expertise to all staff assigned to the clinical program
• Coach and mentor Study Team Leaders and Clinical Trial Managers assigned to program on trial leadership activities and appropriately delegates development opportunities
• May serve as a team lead on non-program/ functional initiative work streams
• Develop good relationships with all important partners. Contribute at Core Team level beyond operations and able to give input into Development strategy
• Help hire and source strategy and improve resources
• Be a primary consultant to senior-level colleagues (eg, Project Team Leaders, Leaders & Medical Directors), functional leadership and stakeholders
• Work is accomplished independently with oversight from VP Development Ops to ensure understanding of broad disease and organizational strategies
• Lead and foster an environment supportive of innovation and smart risk-taking to bring and implement novel approaches to drug development
• Lead staff through organizational change and growth and provide input to senior management on changes and improvements
• Champion change with direct reports, dotted line reports and peers to sustain long-term goals
• Demonstrate core Arsenal’s core values (One Team, Transparency, Humility, Sustainability) and the attributes that support these core values
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Arsenal’s culture

Preferred Qualifications

No preferred qualifications provided.