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Senior Director, Clinical Operations (24130-R-615-MED)
ArsenalBioUKRemotefull_timeVerifiedPosted 7 Nov 2024
💰 $224,500/yr
About the role
WHO WE AREArsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We seek a talented and experienced Clinical Operations Senior Director to work HYBRID based in our SOUTH SAN FRANCISCO office.
ArsenalBio’s mission and purpose are very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.
Driven by a collective of diverse experts across multi-scientific disciplines and clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives.
This means you’ll have the opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM, which advances therapies for patients who need it most.
Clinical Operations facilitates excellence in clinical trial execution and partners with Technical Operations to ensure drug product quality and delivery. The Clinical Operations Senior Director will be responsible for execution of clinical studies and program(s) and will build and manage clinical study teams. This role will work within a matrix team to enable productive interactions across technical operations and clinical functions. This role will require an ability to operate in a fast-paced, highly dynamic environment with partnerships that include both internal and external stakeholders.
ArsenalBio’s mission and purpose are very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.
Driven by a collective of diverse experts across multi-scientific disciplines and clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives.
This means you’ll have the opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM, which advances therapies for patients who need it most.
Clinical Operations facilitates excellence in clinical trial execution and partners with Technical Operations to ensure drug product quality and delivery. The Clinical Operations Senior Director will be responsible for execution of clinical studies and program(s) and will build and manage clinical study teams. This role will work within a matrix team to enable productive interactions across technical operations and clinical functions. This role will require an ability to operate in a fast-paced, highly dynamic environment with partnerships that include both internal and external stakeholders.
WHAT YOU’LL DO
- 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
WHO YOU ARE
- BS or equivalent advanced degree.
- 15+ years of experience in drug development with recent experience in oncology drug development and autologous cell therapy.
- 13+ 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
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