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Global Clinical Operations Program Director

Location Oss, North Brabant, Netherlands Job ID R-156969 Date posted 16/01/2023

“We put patients first”

This year we are expanding our portfolio with new compounds and studies, and we have a promising pipeline. 

We have an unique opportunity for two Global Clinical Operations Program Directors to strengthen our early phase hub for haematological studies and compound development at Acerta Pharma in Oss, The Netherlands. Acerta Pharma is a member of the AstraZeneca Group and together we work tirelessly to bring new therapies to patients with haematological malignancies.

Haematology is driven by speed. Here you will be backed by leadership and empowered at every level to prioritise and make bold moves. Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs.

Are you passionate about leading early phase clinical programs and drug development? Be part of the team that follows the science to transform the lives of patients living with cancer. There is no better place to make an impact, join Acerta Pharma today!

Global Clinical Operations Program Director (2x)
Oss, The Netherlands

Your challenge: 
As our Global Clinical Operations Program Director you are responsible for integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs. You will develop the core clinical operations components for governance interactions with the oversight of the Senior Global Program Director (Sr GPD).  
You lead for cross-functional teams in delivery of clinical program team (CPT) activities assigned. You provide for cross-functional clinical submission teams in support of regulatory marketing applications deliverables.

In addition you will:
•    Lead (functional) cross-functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk.
•    Work closely with Global Study (Associate) Directors to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT)
•    Be responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk).
•    On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in business lead cross-functional teams in delivery of assigned clinical program team (CPT) activities.
•    Mentor, coach and support capability building as appropriate, with potential line management.

Your experience?
•    At least 8 years of relevant clinical experience in the pharmaceutical industry, or a similar organisation (e.g. CRO) including clinical trial leadership experience on global trials.
•    Early phase experience is a must have, oncology experience desirable, haematology experience would be a preference. 
•    Significant experience managing study budgets.
•    Possess strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, empowering critical & strategic thinking, problem solving, and influencing
•    Excellent command of the English language (both written and verbally). 

What we offer:
•    A dynamic, innovative and international working environment. You are part of the development process of new drugs that can make a difference in the lives of cancer patients and their loved ones. 
•    Good primary & secondary benefits including 8% holiday allowance, 25 holidays on a full-time basis plus office closure between X-mas and New Year + Good Friday. 
•    Collective pension with a fixed percentage personal contribution.
•    Bonus scheme. 
•    Personal budget which can be used for vitality, home office equipment, sustainability or personal development. 
•    Access to internal training and learning and development offerings. 
•    You can work partly from home.

For expats:
•    We offer a good relocation package (including support for an application to the tax authorities for the 30% tax ruling).
•    We offer an expat program, including a language course and the opportunity to learn more about the Dutch culture.

The Team
You will work in the Clinical Operations Team in Oss which consists of >25 experienced professionals in various roles. We work closely with AstraZeneca's Haematology Clinical Operations teams and Clinical Development and other functional groups  in Canada, US and UK. Together with our colleagues of Medicinal Chemistry and BioScience in Oss we have an informal culture,  a great team spirit and a willingness to share and learn from each other. We all work for the same purpose: to develop drugs that make a difference in patients' quality of life. The company and the team is looking forward to welcoming new, energetic, experienced and inquisitive colleagues.

Acerta Pharma 
At our international headquarters in Oss, the Netherlands, we are working to develop new treatment options for patients with specific types of blood cancer. Together with our colleagues of AstraZeneca in US, Canada and UK we are committed to innovative drug discovery and development, especially in the field of haematological oncology.

Acerta has received approval from both the US (FDA) and the European Regulator (EMA) for its small molecule BTK inhibitor for treatment of patients with chronic lymphocytic leukaemia (CLL). In addition, AstraZeneca and Acerta Pharma are collaborating on a large number of other innovative medicines to treat haematological malignant diseases.

If you have any questions about this vacancy, our Recruitment Team, Caroline van Oppen, Karin Raadschelders and Maaike Willems are happy to inform you. 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 authorization and employment eligibility verification requirements.

10000929 F CDSM

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.