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Senior Director, Clinical Operations (24130-R-615-MED)

WHO WE ARE

Arsenal 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.



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 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.


BENEFITS AND PAY

ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge. 


Our people-first culture cultivates a deep respect for humanity, not only in those we serve but also in one another. We take pride in being part of a company that values and celebrates diversity—in experiences, ideas, and interests. We are empowered in an environment that embraces unity and inclusivity, fostering a sense of belonging and mutual respect.


We provide powerful tools to empower our employees to take charge of their career paths and reach their full potential. At ArsenalBio, we believe in investing in our employees' well-being—both professionally and personally—because our people are our most valuable asset. Our essential team members bring exceptional expertise in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software, and other fields to turn the possibilities of tomorrow into the realities of today.


We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.


We are an equal opportunity employer and deeply value diversity within our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.


The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $224,500–$275,000. Salary ranges for other locations may vary.  Base pay offered may vary based on job-related knowledge, experience, education, and location. Beyond these considerations, we are committed to pay equity and consider the internal equity of our current employees when making any final offers.


To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias or to ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.


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$224500K
$275000K

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What You Should Know About Senior Director, Clinical Operations (24130-R-615-MED), Arsenal Biosciences

Welcome to Arsenal Biosciences, where our mission is clear: to defeat cancer with innovative and programmable cell therapies! We’re on the lookout for a passionate and experienced **Senior Director, Clinical Operations** to join our hybrid team at our South San Francisco office. In this pivotal role, you’ll lead the charge in executing clinical studies and managing dedicated clinical study teams. Your efforts will contribute directly to our groundbreaking work in cell therapy, where our diverse team brings together specialized knowledge across various scientific domains. As you spearhead the operational and strategic components of assigned programs, you’ll collaborate with both internal and external partners to address the complex challenges posed by solid tumor treatment. With 15+ years of experience under your belt, particularly in drug development and cell therapy, you’ll be adept at handling the fast-paced and dynamic environment we thrive in at ArsenalBio. Your expertise will guide the development of high-level operational strategies, budget planning, and risk assessments, ensuring we stay on track to deliver high-quality therapies to patients in need. Join us as we foster an innovative and supportive culture that not only values professional growth but also champions inclusivity and respect. At ArsenalBio, you won’t just fill a position – you’ll be an integral part of a mission-driven team dedicated to transforming cancer treatment. Together, we engineer the medicines of tomorrow to create a healthier future for all.

Frequently Asked Questions (FAQs) for Senior Director, Clinical Operations (24130-R-615-MED) Role at Arsenal Biosciences
What are the key responsibilities of the Senior Director, Clinical Operations at Arsenal Biosciences?

The Senior Director, Clinical Operations at Arsenal Biosciences is responsible for managing all operational aspects of assigned programs, ensuring the successful execution of clinical studies. This includes collaborating with technical operations, developing operational strategies, overseeing budget and resource allocation, and leading clinical study teams. Strategic input into risk management plans and long-range planning is also a critical part of the role.

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What qualifications are required for the Senior Director, Clinical Operations position at Arsenal Biosciences?

Candidates for the Senior Director, Clinical Operations role at Arsenal Biosciences should possess a BS or equivalent advanced degree and have at least 15 years of experience in drug development, particularly in oncology and autologous cell therapy. Additionally, a proven track record in managing complex clinical trials and teams is essential, along with knowledge of regulatory processes and clinical monitoring.

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How does the Senior Director, Clinical Operations at Arsenal Biosciences contribute to drug development?

In the Senior Director, Clinical Operations role at Arsenal Biosciences, the individual contributes to drug development through strategic oversight of clinical program execution, providing leadership to study teams, and ensuring the alignment of clinical operations with broader development activities. They also play a key role in scenario planning, resource estimation, and budget management to facilitate efficient drug development processes.

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What kind of work environment can the Senior Director, Clinical Operations expect at Arsenal Biosciences?

Arsenal Biosciences offers a hybrid work environment that champions flexibility and collaboration. The Senior Director, Clinical Operations will work within a diverse and dynamic team, fostering an innovative culture that prioritizes respect and inclusivity, allowing for the exchange of ideas and insights crucial for advancing therapies.

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What benefits does Arsenal Biosciences provide to its Senior Director, Clinical Operations?

Arsenal Biosciences offers a comprehensive benefits package, including medical, dental, vision, mental health resources, and flexible work schedules. Employees enjoy generous time off, including additional Arsenal Days of Rest each quarter. The company's people-first culture emphasizes employee well-being, professional growth, and diversity, ensuring that all staff feel valued and empowered.

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Common Interview Questions for Senior Director, Clinical Operations (24130-R-615-MED)
Can you describe your experience managing complex cell therapy studies?

While answering this question, highlight specific examples of cell therapy studies you've managed, detailing the complexities you faced, your approach to tackling them, and the outcomes. This could include aspects such as collaboration across teams, resource management, and strategies employed to navigate challenges in clinical protocols.

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How do you ensure effective communication across multidisciplinary teams?

Effective communication is critical in a multidisciplinary setting. Discuss techniques such as regular updates, the use of collaborative tools, and building relationships that foster open dialogue. Provide examples where you successfully bridged communication gaps to achieve team goals.

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Describe a time you led a team through a significant organizational change.

Use the STAR method (Situation, Task, Action, Result) to outline your leadership during a change initiative. Emphasize your approach to guiding team members, managing resistance to change, and ensuring stability while implementing new processes.

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What strategies do you use to assess risks in a clinical trial?

Discuss your foundational knowledge in risk management along with specific strategies you've implemented, such as risk identification sessions, developing contingency plans, and ongoing risk assessment during a trial. Illustrate your points with real-life examples.

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How do you prioritize multiple projects in a fast-paced environment?

Share your organizational techniques, such as using project management tools, setting clear priorities based on impact and urgency, and regular reviews of progress. Provide an example of juggling multiple projects and how your strategies led to successful outcomes.

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What role do you see yourself playing in developing target product profiles (TPPs)?

Describe your understanding of TPPs in developing cell therapies. Talk about how you would contribute to defining optimal characteristics and outcomes for drug candidates and your experience with scenario planning that informs TPP development significantly.

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Can you share an experience where you had to influence senior management on a key decision?

Detail a specific instance where you effectively presented critical data or insights that influenced decision-making at a senior level. Discuss your preparation, the metrics you highlighted, and the outcome of that engagement.

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What do you believe are the core values that should guide a Clinical Operations team?

Discuss values such as teamwork, transparency, accountability, and innovation. Explain how these values drive your leadership style and decision-making process, fostering a strong and effective operational environment.

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How do you approach coaching and mentoring your team members?

State your philosophy on team development, focusing on personalized guidance, regular feedback, and creating opportunities for growth. Share a specific success story that illustrates your mentoring approach and its impact on team performance.

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What is your understanding of the regulatory processes involved in clinical trials?

Provide an outline of the key regulatory processes, such as IND submissions and FDA interactions, emphasizing your experience with compliance and best practices in ensuring trials meet regulatory standards throughout their lifecycle.

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ArsenalBio is a privately-held clinical stage programmable cell therapy company engineering advanced CAR- T therapies for solid tumors. ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases,...

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Full-time, hybrid
DATE POSTED
December 13, 2024

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