Senior Clinical Research Scientist - Late RIA

Are you a highly motivated, interactive and creative Scientist ready to work in a matrix environment to advance Clinical Drug Development programs? If you can envision providing scientific expertise in a role that can impact patients' lives - join us today!

Our overall research ambition within Respiratory, Inflammation and Autoimmune (RIA) for the future is to transform the lives of patients through our growing portfolio of inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification with the ambition of achieving remission or even cures for patients.

In this role, you will provide scientific and clinical input to all aspects of late stage product development. This includes design, delivery and interpretation of pivotal clinical trials, mechanistic studies, studies that further characterize the overall benefit, risk value of RIA Therapeutic Area (TA) products and in late stage development and other indications.



Main Duties and Responsibilities

The objectives of the Clinical Research Scientist/ Senior Clinical research Scientist will be set by the Group Director in agreement with Global Clinical Lead(s). Your role will have a special focus on late stage clinical trials within RIA, where you will work in close collaboration with the study team physician with all aspects of scientific input, clinical data quality metrics and safety evaluation.

You will be encouraged to collaborate with colleagues in the RIA development and early development groups. To be successful in your role, you will seek input from the appropriate functional experts and coordinate these activities in support of clinical studies and programs.

Furthermore, you will ensure that the safety evaluation process is seamless and complete and independently lead specific activities and contribute to science story preparation, regulatory submissions, process improvement and mentoring other scientists.



We will rely on you to:

* Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
* Effectively work together with colleagues in other functions including Patient Safety, Regulatory Affairs, Clinical Operations and early development groups.

* Be involved primarily in late stage (Ph2b and Phase 3) clinical programs but will be encouraged to collaborate with clinical colleagues supporting early stage programs as well as medical affairs colleagues.
* Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities.
* Provide authoritative scientific analysis and interpretation of data from ongoing studies and in the literature.
* Lead development of quality metrics and data review plan for assigned studies
* Support and contribute to medical monitoring of trials
* Lead and participate in activities that ensure quality, consistency and integration of clinical study related deliverables and ensure safety evaluation process within the clinical team.
* Ensure scientific input to TA standards
* Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments.

* Support and contribute to medical monitoring of trials
* Lead development of quality metrics and data review plan for assigned studies
* Develop and review protocols, informed consent and investigator's brochure.
* Renowned expert in own field and may specialize in more than one area. May coordinate the activity of a research team and holds full accountability for projects, often with Global impact.



Essential Requirements

You have a science or medical degree (e.g. MS, MD, PhD or PharmD), complemented by considerable relevant experience in respiratory, inflammatory or autoimmune diseases clinical trials from pharmaceutical industry or academia.

* Good transferable project experience across phases I - III drug development.
* Experience managing and interpreting the results of clinical trials as well as exposure to writing protocols to some degree and/or contribution to key study documents and processes. .
* Strong analytical skills and experience of authoring scientific documents.
* Sufficient technical and disease area knowledge to be able to interact with confidence with internal and external partners.
* Excellent verbal and written communication, presenting scientific results to multidisciplinary teams and key partners.



Desirable Requirements

* Experience leading and managing activities that require cross functional collaboration, good communication and passion for customers.



If you are ready to make a difference - apply today, and we'll make it happen together!

Welcome with your application no later than April 30th, 2020