Associate Director Study Leader

4 weeks ago

Gaithersburg, United States Neogene Therapeutics Full time

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values 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.

Why AstraZeneca?

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 affect 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 Associate Director (AD) Study Leader Cell Therapy delivers a single or several smaller Cell Therapy developments programs or leads multiple Cell Therapy studies or single complex/novel studies such as platform, basket. The exact accountabilities will differ depending on the nature of the clinical program or study. You will report to the Sr. Director Group Leader, Cell Therapy or equivalent.

The ADSL may provide expert input to other non-drug programs and process improvement projects.

Essential Skills:

  • Provide expert clinical operational input into project or study level documents, and may lead the delivery of study documents
  • With oversight from the Sr. Director Group Leader, Cell Therapy or the Clinical Program Director, Cell Therapy, may lead and deliver operational options for review at Investment Decision Governance interactions
  • Lead the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
  • Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program
  • Manage risk management/mitigation plans to ensure delivery to quality, budget and time and escalate issues to partners.
  • Provide input to forecasting and management of study/program delivery costs, resource, and timelines
  • Accountable for the quality of study/program planning information into relevant planning systems
  • Responsible for oversight of CROs and other clinically outsourced third-party vendors for outsourced studies and programs
  • Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • Provision to procurement clear specifications for study or program specific outsourcing
  • Review and operational approval of study or program specific contracts or work orders
  • Lead and conduct investigator meetings and other study related meetings. May convene and lead the Study Teams for EO Cell Therapy studies.
  • Identify areas of best practice / process improvements and knowledge share across the Cell Therapy Clinical Group.
  • University degree/Bachelor's degree in related discipline in medical or biological science.
  • 5years experience in clinical research, with at least 3 years of global study leadership or equivalent
  • Excellent knowledge of ICH-GCP principles
  • Experience and strength in working and leading in matrix teams
  • Experience in selection and oversight of external providers and development of contracts
  • Experience in variety of academic/CRO/Sponsor organizations and countries
  • Experience in autologous or allogeneic therapies in oncology

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.

The annual base salary for this position ranges from $154,000 to $186,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience.

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.

Ready to join our team and make a difference? Apply now

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.

DE&I Statement

Headline: We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

  • Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
  • A collaborative culture that leverages the diverse perspectives of employees and supports courage
  • Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."

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