At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re 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’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The Senior Project Scientist 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 and risk and value of Respiratory products in late stage development.  The Senior Project scientist ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete.

In this role the clinical scientist would seek input from the appropriate functional experts and coordinates these activities in support of clinical studies and programs.  The objectives of the Senior Project Scientist will be set by the Group Director in agreement with Global Clinical Lead(s). The role will have a special focus on late stage clinical trials within the respiratory where the Senior Clinical scientist will work in close collaboration with the study team physician 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 from target identification/validation through IND enabling activities. You will be expected to effectively collaborate with colleagues in the respiratory development and early development groups. Other capabilities are to demonstrate clear and professional verbal and written communication, presenting scientific results to multidisciplinary teams and key stakeholders. Work as a member of a diverse and motivated team of researchers spanning across multiple divisions of GMed. The Senior Scientist lead independently some activities and contribute to ie. regulatory submissions, process improvement and mentoring other scientists.

• Providing scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
• Expected to effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations, and early development groups.
• Be involved primarily in late stage (Ph2b and Phase 3) clinical programs, but will be expected 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 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
• 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.
• Capable of presenting scientific results to multidisciplinary teams and key stakeholders
• 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, investigator’s brochure.

Qualifactions:

• Scientific doctoral level degree (e.g. PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with extensive experience from clinical development.
• Five or more years of relevant pharmaceutical industry experience (multi-country clinical trials) is required. 
• Understanding of scientific and clinical issues related to the design and implementation of clinical trials and interpreting trial results.
• Proven ability to work collaboratively in a cross-functional setting, particularly with patient safety, vendors, CRAs, Site staff and clinical operations.
• Experience, particularly Phase II and Phase III clinical development and experience with regulatory submissions, life cycle management, advisory boards, annual safety updates.

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.