WHO WE ARE

Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Vice President, Clinical Operations to work onsite/hybrid based in our South San Francisco office.

ArsenalBio's mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal 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 as well as 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 advancing therapies for patients who need it most.

Get ready to make a major impact! Clinical Operations is the heartbeat of our clinical trial excellence, driving the future of medicine hand in hand with Technical Operations to guarantee top-tier drug quality and timely delivery. We are seeking a dynamic, passionate and experienced senior Clinical Operations leader to partner closely with the Chief Medical Officer to provide strategic vision and operational excellence in the execution of clinical trials.

In this pivotal role, you will be at the forefront, building and leading our clinical operations team, through study planning and execution, vendor partnerships, and ensuring our trials run like clockwork—all while maintaining the highest standards of GCP compliance. We seek a highly collaborative leader with a wealth of experience working with CROs and leading interactions with investigator sites to power our trials with unmatched efficiency in a complex, ever-evolving landscape.

This is your chance to thrive in a fast-paced, high-energy environment, collaborating with both internal teams and external partners to bring transformative treatments to patients. If you're ready to lead the charge and make a real difference, this is your opportunity!

WHAT YOU'LL DO

Accountable for successfully executing clinical studies and programs to meet pertinent timelines and clinical milestones.
Develops the clinical operations strategy to include risk management and contingency planning
Demonstrate a high level of expertise with operational processes and requirements, effectively applying this knowledge to lead the clinical operations function to achieve corporate objectives
Understand the patient journey in clinical trials and potential patient safety and logistic issues to optimize the team's recruitment strategies
Establish, monitor and report on performance standards and metrics for the execution of clinical projects with a focus on the proactive identification of issues and implementation of appropriate corrective actions
Identify and implement innovative solutions to resolve roadblocks in patient recruitment and clinical trial execution
Build relationships with investigators/site personnel and CROs/other contractors to drive effective communication and collaboration for the most successful clinical trials
Own clinical operations budget and provides forecasts and monitoring of budgets across all clinical programs for near-term and long-range planning by developing accurate assumptions and prudent allocation of resources
Identify, evaluate, select, manage, and provide oversight of CROs/other contractors; this role is the primary point of contact for escalation of issues, including development of risk mitigation strategies
Utilize a robust and creative approach to maximize the value of CRO activities with a rigorous approach to budgetary control
Implement best practices and standards for trial management in collaboration with other members of the clinical team, including the establishment of SOPs
Collaborate with Quality Assurance, Regulatory, and Clinical to ensure that clinical trials meet compliance, regulatory, and patient safety requirements
Establish and maintain strong partnerships with CRO's, partners, vendors, and external stakeholders.
Provide oversight, mentorship and career development opportunities to direct reports.
Represent the company as a senior clinical operations spokesperson before appropriate scientific, medical, regulatory, business associates and others in professional meetings.

WHO YOU ARE

BS or equivalent; advanced degree preferred.
15+ years of experience in building and managing complex clinical operations teams- a fast-paced, high-growth biotech companies
Proven track record of managing complex cell therapy, autologous cell therapy, and early to late phase studies, preferred.
Proven track record of managing programs across all phases of clinical development, including successful FDA inspections and audits
Experience conducting complex clinical programs across multiple geographies
Knowledge of advanced information technology systems to facilitate complex clinical monitoring and sample tracking.
In-depth knowledge of GCP guidelines, FDA regulations and clinical operations development processes.
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 fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We are proud to work for a company that is driven by diversity in experiences, ideas and interests, and one that empowers us in an environment that embraces both unity and inclusivity.

We have robust tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as our people are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

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 value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $273,500-$335,000. Salary ranges for other locations may vary. Base pay offered may vary based on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.

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

Arsenal Bio

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