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Senior Global Study Manager- Cell Therapy

Employer
Neogene Therapeutics
Location
Gaithersburg, MD
Start date
Jun 7, 2024

View more

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 Senior Global Study Manager, Cell Therapy leads the operational activities to support and ensure the delivery of cell therapy clinical studies ensuring quality and compliance. The accountabilities will differ depending on the nature of the clinical program or clinical study.

Responsibilities

Provide operational expertise to the Study Team.

  • Lead the development of study documents and any updates/amendments, ensuring template and version compliance.
  • Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
  • Provide mentoring and guidance to the operations team ensuring collaboration and communication with the Study Team.
  • Provide input to data management documents and interface with data management representatives and sites to help deliver study data.
  • Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and help track spend against approved budget.
  • Ensure the supply of study materials and ensure the appropriate allocation of apheresis/manufacturing slot availability by partnering with Cell Therapy Operations (CTO) or external service providers as appropriate.
  • Oversight of third-party vendors, global / local internal staff, and investigator sites to support delivery of a study and its regulatory documents.
  • Provide oversight of and support recruitment and data delivery and risk mitigation strategies.
  • Oversee the clinical trial insurance process, track approvals, revisions, and renewals of certificates.
  • Monitor study conduct and progress, resolving issues which may affect delivery of the study to the necessary quality, timelines, or budget.
  • Guide risk management and quality efforts to ensure study compliance.
  • Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring inspection readiness.
  • Prepare presentation material for meetings, newsletters, and websites.
  • Direct the Study Team in the implementation of audits and regulatory inspections.
  • Identify areas of best practice / process improvements and knowledge share across the Cell Therapy Clinical Group.
  • Contribute to review of new/amended/unique SOPs and guidance documents.

Experience and Education

  • Bachelor's degree in medical or biological science, or discipline associated with Clinical Research, or equivalent experience.
  • Minimum of 5 years clinical trial experience, of which at least 2 years are in global study management United States only.
  • Bachelor's degree and 5+ years, Associate's degree plus 9+ years or High School plus 13+ years of experience, of which at least 2 years are in global study management.
  • Excellent knowledge of ICH-GCP principles.

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 $126,000 to $174,000. 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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