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Clinical Scientist

To support the expansion of AM-Pharma’s business, we are currently looking for a Clinical Scientist

Job

About the role

At AM-Pharma, we are actively conducting a global Phase III program treating critically ill patients with acute kidney injury in partnership with a clinical research organization. In addition, we are in the process of starting clinical research in a second and third indication and this will likely be executed in the same format. We have also started our preparations for commercial readiness that includes the build of the appropriate organization. As Clinical Scientist, you support our global drug development activities by
• providing scientific, clinical and operational input to clinical development studies with emphasis on protocol-specific and clinical data monitoring activities; this includes protocol and study design, data review, interpretation and presentation;
• elaborating, reviewing and updating clinical documents including SAP, protocol/amendments, medical review documents, training material, informed consent documents, study reports, PK reports, protocol deviation list, input to data management activities (e.g. electronic data capture, data review plan, case report forms) etc.;
• working with the cross-functional clinical trial teams on design, execution and monitoring of clinical trials as well as data interpretation and communication;
• supporting our Clinical Trial Site Liaisons (EU and US) with clinical input;
• working closely with medical on medical data reviews, coordinating DMC meetings and TSC meetings.
• Supports publications/presentations as needed

Start date

As soon as possible

Profile

What we expect

We expect our Clinical Scientist to have
• PhD degree in Biomedical (Pharmacology, Biology, Chemical Engineering etc.)
• Relevant experience in clinical development and providing clinical scientific advice
• Excellent interpersonal, verbal and written communication skills
• Ability to plan, organize, prioritize and execute multiple tasks within assigned objectives
• Ability to work effectively in an international matrix team and value the importance of teamwork
• You can deal with peaks in the planning, a high workload and the ad-hoc and fast paced nature of biotech
• Fluent knowledge of English (written and oral)
• Advanced knowledge of MS Office (Word, PowerPoint, Excel)

Benefits

Remuneration

Salary at market level, depending on education and working experience
Company pension scheme (100% contribution by employer)
Mobile phone
Full reimbursement of public transportation or travel allowance of Euro 0,19 per km

Company profile

About AM-Pharma

AM-Pharma is a clinical-stage biopharmaceutical company developing proprietary recombinant human Alkaline Phosphatase (AP) therapeutics. Its most advanced asset, known as Ilofotase Alpha (or recAP), is a fully human recombinant form of AP. In 2018, the company successfully completed a Phase IIb trial in sepsis-associated acute kidney injury patients (SA-AKI). The focus has since been on funding and execution of the Phase III / registration trial and preparation for launch. The company is gearing up to build the organization that will deliver on the next phase of evolution.
The new AM-Pharma organization has involved several new key positions with large pharma / biotech Phase III experience. The focus will be on Operational Excellence and flawless execution of pivotal studies with the objective to deliver a quality market authorization submission package and to be ready for launch. The bandwidth of the organization will allow for expanding the pipeline and/or accommodating new strategic opportunities.

AM-Pharma company culture

The company culture of AM-Pharma is built on four important competences: Collaboration, Quality orientation, Accountability and Resilience. At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company above our own individual interest. We set high standards regarding the quality of our materials, processes, documentation and collaborations, the staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work. Finally, we understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.

Contact

To apply

Please send your CV and cover letter, stating the title of the position you are applying for,
to hr@am-pharma.com.

Location Utrecht
Clinical Scientist

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