The Scientific Director brings expert knowledge about AKI-related research to the company to support mode-of-action and biomarker evaluation, label extension, life cycle management and the scientific platform activities. You support the CMO and VP Research by outsourcing and leading disease-related projects to further the scientific understanding of mechanisms in (sepsis and) AKI and the mode of action of alkaline phosphatase. You understand clinical science and clinical development and contribute to translational work, linking to both Research and Development. You design research development plans and transfer these into concrete actions. You build effective research collaborations (with e.g. CRO, Academia), co-interpret scientific results and actively contribute to scientific publications, presentations, patent applications and the documentation critical to enter the next stages of product development. You contribute to pre-clinical proof of concept and work together with external parties on the development of Sepsis and AKI-related product concepts. You share knowledge to keep AM-Pharma fully up-to-date on the latest news and developments in the industry. You work closely together with Clinical Development professionals to develop and qualify methodologies for non-clinical and clinical trials enabling registration of new therapeutic products.. You conduct scientific evaluations to identify novel targets and to select suitable disease indications together with a multidisciplinary team. You keep up to date with latest development in the field, such as novel technologies and requirements for regulatory documents. Finally, you write reports, manuscripts and study protocols and contribute to regulatory documentation.
We expect our Scientific Director to:
· Keep an MSc degree in biology, biomedical sciences, chemistry, Life sciences or equivalent and a PhD degree in a relevant area (biology, biomedical science, chemistry, medicine)
· Have a background in immunology, in vitro and in vivo pharmacology, molecular biology; preferably gained experience in renal, lung or liver physiology
· Bring a minimum of 10 years of relevant work experience as translational research leader in biotech or pharma
· Have a proven affinity with (bio)pharmaceutical research and translational science; experience with effectively driving collaborations and CROs to results
· Be good at planning and organizing skills and have excellent analytical skills
· Be a results-oriented team player; pro-active and hands‘on, pragmatic and solution-oriented attitude
· Have great data reporting and presenting skills (internally/externally) and communication skills
· Be able to show scientific leadership and to be self-dependent
· Have the ability to work successfully in a small organization.
At market level.
We expect the candidate to start its employment in Q4 2020.
AM-Pharma is located in the brand-new WTC Utrecht, adjacent to Utrecht Central Railway Station in the lively business heart of Utrecht, close to Amsterdam and Schiphol Amsterdam Airport.
AM-Pharma is a clinical-stage biopharmaceutical company developing proprietary recombinant human Alkaline Phosphatase (AP) therapeutics. Its most advanced asset, known as 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 preparing to launch the Phase III / registration trial. 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. 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.
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