Associate Director, Clinical Business Operations - South San Francisco, United States - Arsenal Biosciences

Arsenal Biosciences

Verified Company

South San Francisco, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 adhoc 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
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 crossfunctional 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 multitask 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 fastpaced 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 - bo