At AstraZeneca we are guided in our work by a strong set of values and are resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods and thinking, and bring unexpected teams together. From scientists to sales, lab techs to legal, we are on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you are our kind of person.

The Clinical Research Scientist (CRS)/Senior (Sr) CRS will provide scientific and clinical input to all aspects of late stage product development. This includes but is not limited to the design, delivery, and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit, risk, and value of late stage development products in the respiratory, inflammation, and autoimmunity (RIA) therapeutic area (TA).

In this role, the CRS/Sr CRS provides input and has responsibilities and accountabilities in support of clinical studies and programs. The objectives of the CRS/Sr CRS will be set by the Group Director in agreement with the specific product Global Clinical Lead(s). The role will have a special focus on late stage clinical trials within the RIA TA where the CRS/Sr CRS will work in close collaboration with the study team physician and other internal stakeholders with all aspects of scientific input, clinical data quality metrics, and safety evaluation.

You are a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance clinical drug development programs throughout the clinical development process leading to IND submissions and inspections. You will be expected to effectively collaborate with colleagues within Late RIA and early development groups. Other capabilities are to demonstrate clear and professional written and verbal communication, including presenting scientific designs and results to multidisciplinary teams and key stakeholders. You will work as a member of a diverse and motivated team of researchers spanning across multiple divisions and geographies within Biopharmaceuticals R&D. The CRS/Sr CRS works both independently and collaboratively within activities and contributes significantly to regulatory submissions, process improvement, and mentoring.

Key activities and leadership areas

• Provide scientific leadership in the innovative design, execution, and interpretation of clinical trials in one or more development programs
• Effectively collaborate with colleagues in other functions including Clinical Development, Patient Safety, Regulatory Affairs, Clinical Operations, Global and US Medical Affairs, and Early RIA
• Provide expert scientific input into the preparation of regulatory documents and interactions
• Provide expert 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
• Contribute to and support medical monitoring of trials
• Lead and participate in activities that ensure quality, consistency, and integration of clinical study related deliverables
• Ensure scientific input to TA standards
• Provide scientific evidence to support strategic decision making for R&D, clinical, marketing, medical affairs, and business development departments
• Present protocol, scientific results, and other key information to multidisciplinary teams and key stakeholders, including presenting at investigator meetings
• Develop and review protocols, informed consent forms, investigator’s brochures, electronic data capture forms, other key clinical development documents

Qualifications

• Scientific doctoral level degree (e.g. PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with extensive experience from clinical development or medical affairs
• Scientific and clinical expertise related to the design and implementation of clinical trials and interpretation of trial results.
• Proven ability to work collaboratively in a cross-functional setting
• Experience, particularly Phase II and Phase III clinical development and experience with regulatory submissions, life cycle management, advisory boards, annual safety updates is ideal
• Five or more years of relevant pharmaceutical industry experience (multi-country clinical trials) is ideal 
• Availability to travel, including international, may be required

Date Posted

Closing Date

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.