Associate Director, Clinical Business Operations (24113-R-615-Clin)

ArsenalBio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Associate Director, Clinical Business Operations to work hybrid or remotely.

ArsenalBio's mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.

ArsenalBio is seeking an Associate Director, Clinical Business Operations to join Clinical Operations. You will be responsible for ensuring efficient and accurate clinical trial study cost reporting and forecasting, creating, reviewing, and monitoring clinical site and vendor contracts and budgets to ensure consistency and alignment across studies and programs, and developing robust processes and building efficiencies across clinical programs to optimize financial oversight. This role will require an ability to operate in a fast-paced, highly dynamic environment within a matrix team and have partnerships that include both internal and external stakeholders.

What You Will Do:

• Support clinical benchmarking and site budget development, escalation, and payment activities for clinical sites, CROs, and lab vendors

• Develop and implement a robust, scalable, and efficient site contracting and budgeting process and oversight across all studies

• Work with the ArsenalBio Finance, Clinical Operations, and Clinical Data management teams to support financial reporting activities including reconciliation of clinical site/vendor invoices and payments

• Able to assist with full study cost projections, not limited to site costs only; as well as provide commentary on BvA to strive for more accurate forecasts and cost modeling.

• Oversee and manage CRO, site, and vendor contract negotiation activities, escalation, execution, and monitoring while collaborating with the CRO and ArsenalBio Legal and Clinical Operations teams

• Communicate directly with clinical sites to assist with contract and budget negotiations

• Attend study team meetings to oversee CRO site budget negotiation activities and contract execution to ensure successful timeline management of site activation and protocol amendment implementation

• Oversee and manage CRO and vendor performance using metrics and KPIs

• Review site contract trends and develop metrics and process improvement

• Ensure clinical programs are executed within the projected budget and promptly communicate any change in the scope of budget

• Manage all activities in accordance with applicable ArsenalBio SOPs, FDA, & ICH guidelines, and regulations.

• Provide ad-hoc reporting, analysis, and project support for budget governance

• Initiate requisition requests for clinical vendors through Point Purchasing and own and amend the purchase order through the final payment

• Support clinical program teams with long range planning, scenario analysis, and annual budget planning activities

What Will You Bring:

• Your whole self

• BS/BA degree and 10+ years of development/study budgeting, forecasting or financial analysis experience

• Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions

• High level knowledge of clinical operations terms and processes

• Required Advanced Excel skills

• Proficient in using Smartsheets, Google applications, and Microsoft applications

• The Development and implementation of new ideas and solutions to increase efficiency

• Strong analytical, negotiation, and persuasion skills

• Experience working with clinical sites and sponsors is required; working with clinical lab is preferred

• Experience with vendor management & CRO oversight

• Clinical research knowledge and cross-functional understanding of the clinical trial methodology

• Ability to deal with time demands, incomplete information, or unexpected events

• Attention to detail required

• Outstanding organizational skills with the ability to multi-task and prioritize

• Excellent interpersonal, verbal, and written communication skills

• Creative and innovative mindset to approach novel problem statements

• Willingness to learn and adapt to new technologies

• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

What We Will Offer You:

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.

We have a robust mentorship program, and comprehensive development 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 they 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 offer for the preferred primary location of San Francisco Bay Area ranges from $169,000 - $207,000. Salary ranges for other locations may vary from this range. Base pay offered may vary depending 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.

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