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Global Study Associate - Cell Therapy

Employer
Neogene Therapeutics
Location
Gaithersburg, MD
Start date
Jun 8, 2024

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Discipline
Science/R&D, Biotherapeutics
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work

Job Details

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Study Associate, Cell Therapy is responsible for supporting the delivery of cell therapy clinical studies by providing administrative and system support. The Study Associate will work across several studies, so a high degree of flexibility is required. The exact accountabilities will differ depending on the nature of the clinical program or study. You will report to the Director Study Leader, Cell Therapy or equivalent.

 

Responsibilities

  • Collect, review, and track relevant study documents.
  • Support setup, maintenance, closeout and archiving of the Trial Master File (TMF), including restricted TMF sections for Cell Therapy-specific documents. Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
  • Support production of study documents, ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system.
  • Set-up, populate and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems.
  • Manage and contribute to the coordination and tracking of study materials and equipment.
  • Assist in the tracking and reconciliation of invoices.
  • Support study team and provide study metrics/reports during the study, audits, and regulatory inspections.
  • Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g., study team meetings, monitor meetings, investigator meetings and advisory boards.
  • Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents.
  • Prepare and distribute study-related correspondence. Contribute to and distribute materials for meetings, newsletters, and websites.

 

Education and Experience

  • Bachelor's degree plus 1+ years, Associate's degree plus 6+ years or High School plus 10+ years of experience
  • Minimum of 1-2 years' experience of administrative/operational support of clinical studies
  • Knowledge of ICH-GCP principles
  • Team oriented
  • Ability to coordinate and prioritize multiple tasks and deliverables
  • Proactive approach to accomplishing study goals
  • High degree of flexibility
  • Demonstrated verbal and written communication skills

 

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $79,000 to $119,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an “at-will position” and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

 

Benefits

  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program
  • 401(k) plan
  • Paid vacation and holidays; paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage.

 

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Company

Neogene Therapeutics is a global, preclinical stage biotechnology company pioneering the development of next generation, fully individualized engineered T cell therapies for a broad spectrum of cancers.

Our proprietary neoantigen T cell receptor (TCR) discovery and T cell engineering platform identifies TCR genes with specificity for neoantigens – found exclusively on cancer cells as a result of cancer-associated DNA mutations.

Cancer is a genetically individual disease – no two tumors are exactly the same. These variations create neoantigens – unique targets for every tumor. Neogene’s novel approach delivers a tailored T cell therapy containing a unique set of specific TCR genes for each individual patient. Engineered into patient-derived T cells, these TCRs are directed toward neoantigens in tumor cells, with the goal of eliciting strong and durable responses in a variety of solid tumor indications.

We offer the opportunity to join a highly dynamic biotech start-up. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Company info
Website
Location
2225 Colorado Avenue
Santa Monica
CA
90404
United States

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