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Associate Director, Translational Sciences Operations (24207-U-615-MED)

ArsenalBio

ArsenalBio

Operations
South San Francisco, CA, USA
Posted on Wednesday, May 22, 2024
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 Translational Sciences Operations Associate Director to work 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.
The Translational Sciences Operations Associate Director will provide leadership and day-to-day support on biospecimen management for multiple clinical oncology trials. Near-term goals include developing and implementing procedures to ensure that samples from early-phase studies at external repositories are accurately routed to analytical labs, tested promptly, and properly annotated and reconciled across inventory databases. Long-term objectives include defining strategies to develop the Translational Operations function to support a maturing organization with an expanding portfolio. Communication and alignment with various internal and external stakeholders are key aspects of the role.

WHAT YOU’LL DO

  • Drive the Translational Operations strategy for new studies, aligning with internal stakeholders and achieving milestones within defined timelines and budgets
  • Manage operational aspects of clinical biospecimen collection, routing between external labs, tracking, annotation, and inventory reconciliation
  • Develop and maintain a system for integrating sample metadata from multiple sources into a single, accessible spreadsheet or database
  • Forecast schedules for batch testing based on study enrollment projections
  • Liaise with translational scientists, assay development experts, clinical teams, and external labs to establish biospecimen handling procedures consistent with scientific and clinical needs
  • Collaborate with Clinical Operations and lab vendors to develop lab specifications, manuals, flow charts, and requisition forms consistent with the study protocol and designed with data harmonization in mind
  • Provide expert guidance on the operational feasibility of clinical study plans, including costs, timelines, risks, and resource requirements
  • Identify potential lab vendors, collaboratively establish selection criteria, and work with the legal team to establish contracts
  • Oversee ongoing lab vendor relationships, including project planning, budgeting, performance monitoring, and regular communication
  • Ensure compliance with GCP/GLP best practices and work with the Quality team to monitor and assess vendor performance
  • Track spending and project future budgetary needs
  • Provide ad-hoc reporting and analysis of sample management metrics
  • Review consent forms and other study documents from a Translational Operations perspective to achieve consistency across protocols and alignment with applicable specimen storage and retention policies
  • Travel to the South San Francisco office as required

WHO YOU ARE

  • BS/BA in science or health-related field with 12 years experience of related clinical or translational operations experience (or MS/MA with 10 years experience, or PhD with 5 years experience)
  • Experience in developing, reviewing, and implementing departmental SOPs and processes
  • Ability to maintain detailed decision logs to document and track key events throughout the product life cycle, ensuring transparency and accountability
  • Successful in identifying issues and taking proactive action in escalating and resolving
  • Proven experience reviewing consent forms and study documents from a Translational Operations perspective, ensuring consistency across protocols and alignment with applicable specimen storage and retention policies
  • Outstanding organizational, verbal and written skills with the ability to multitask and prioritize effectively
  • Familiar with translational assays used in cell therapy or immune-oncology
  • Insightful and creative analytical and problem-solving skills
  • Strong spreadsheet skills (Excel or Google Sheets) with a desire to assist in the creation of training materials
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 $169,000 – $207,000. 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.