Global Study Leader Early Oncology
The Clinical Operations Team in Early Oncology is expanding! We are looking for a strong and ambitious Global Clinical Study Lead Early Oncology at Acerta Pharma in Oss, The Netherlands, who is looking for a new career opportunity!
Acerta Pharma is a member of the AstraZeneca Group and together we work on a wide early oncology pipeline, where Acerta Clinical Operations play a significant role in drug development and study operations.
This is a great opportunity to bring your clinical operations experience to our science driven and patient centric global study teams. You will work in a vibrant and dynamic international team. As the Global Study Lead you will be end-to-end responsible managing challenging and complex early oncology studies.
Global Study Lead Early Oncology
Full-time (with good working from home possibilities)
As a Global Study Leader Early Oncology you will be leading international early oncology (phase I/II) studies ensuring the delivery end to end of those projects with quality and compliance. You will work in a cross-functional environment with colleagues from various departments and from different locations. You will be functional responsible for your project team and as a strong motivator with an excellent helicopter view you can bring them to the next level.
In the portfolio we have a big variety of studies like First Time in Human studies, big platform studies, DDI studies as well as small studies with healthy volunteers. You will work with (combinations of) targeted therapy, immune oncology and in the near future with CAR-T compounds.
In this role you will report to one of the Group Associate Directors Clinical Operations based at our offices in Oss and operationally you will report to the Program Director of the compound.
What will you be doing?
• Lead the delivery of the clinical study from concept to final Clinical Study Report (CSRR) to agreed budget, time, project standards, quality and scientific standards.
• Lead the global clinical operations team of (Sr) Global Study Manager(s) and Global Study Associate.
• Lead the global cross-functional study team based on delivery model (outsourced vs insourced).
• Responsible for study level reporting of progress, risks and issues to the Clinical Program Director.
• Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment.
• Responsible for oversight of CRO’s and other clinically outsourced third party vendors for outsourced studies.
• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative.
• Contribute to preparation and delivery of study documents.
• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance.
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
What do you bring?
• Bachelor’s or Master's degree in related subject area, preferably in medical or biological science.
• Minimum of 5 years progressive experience in clinical research, with at least 3 years of clinical development project management experience or equivalent.
• Comprehensive knowledge of the clinical and pharmaceutical drug development process.
• Excellent knowledge of ICH-GCP principles.
• Extensive and proven experience in driving operational delivery to timelines, cost and quality.
• Experience and strength in working and leading in matrix teams.
• Strong collaborative communications skills, including the ability to engage with a diverse client base and manage through conflict.
• Proven ability in problem solving and issues management that is solution focused.
• Competences: strong helicopter view, strong project management skills, excellent problem solving skills, able to manage priorities and you can work with deadlines and pressure and know how to handle and manage this.
• Excellent knowledge of the English language.
What do we offer you?
• Dynamic, innovative and international working environment. You are part of the journey to bring new treatment options to patients that can make a difference for them and their loved ones.
• Work together with your international colleagues from AstraZeneca in the UK and US on the best and international early oncology studies.
• The opportunity to really develop yourself! Talent development and coaching are important for us.
• The opportunity to work in a vibrant, diverse and international team, where you can learn and grow. There is a great atmosphere which we believe is important for working as a team, constantly motivating each another.
• The opportunity to develop and grow with a clear career path.
• Good salary and good benefits including 8% holiday allowance, 25 days' leave on a full-time basis. You can work from home, collective pension with a fixed percentage, bonus scheme and laptop. Wellbeing of our colleagues is important to us, which is why you can exercise at a discount or make use our bicycle plan.
• We offer you an annual contract with the intention to extend this to an indefinite contract after one year.
You will work in the Clinical Operations Team in Oss which consists of around 25 experienced professionals in various roles. We work closely with AstraZeneca's Early Oncology Clinical Operations teams in Cambridge and Gaithersburg. The culture is informal, a great team spirit and a willingness to share and learn from each other. We all work with the same goal: to bring new treatment options that make a difference in patients' life.
The team is looking forward to welcoming new, energetic, experienced and inquisitive colleagues.
At our international headquarters in Oss, over 60 colleagues are working hard to develop new treatment options for patients with specific types of (blood) cancer. We are committed to innovative drug research and development, especially in the field of hematologic oncology.
We work closely with AstraZeneca, which acquired a majority stake in Acerta Pharma in February 2016. In the meantime, we have approval from both the US (FDA) and the European Regulator (EMA) for our treatment for patients with chronic lymphocytic leukaemia (CLL). In addition, AstraZeneca and Acerta Pharma are collaborating on a large number of other innovative medicines with small molecules and biologic drugs to treat certain oncological diseases.
If you are interested and would like to apply we would like to receive your cover letter and CV. You can upload your CV and cover letter at the bottom of the second page.
If you have any questions about this vacancy, our Recruitment Team, Caroline van Oppen, Karin Raadschelders and Maaike Willems can be reached at firstname.lastname@example.org or by phone on +31(0)85 - 047 0244.
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 authorisation and employment eligibility verification requirements.