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.

To foster our growth AZ seeks a Senior Study Physician / Study Physician in Early Clinical Development to help to ensure AZ’s continued success in these strategic therapeutic areas through innovative research and outstanding scientific leadership.

The Study Physician will support the planning, implementation and daily operation of drug development projects across the cardiovascular, renal and metabolic therapeutic areas or respiratory.  The person will collaborate with key internal and external stakeholders and will be likely to serve as project Medical Monitor on one or more projects.  The Study Physician will also be supporting Early Clinical Development (ECD) responsibilities and contributions to internal teams of clinical development professionals/program teams and workstreams responsible for delivering Drug Development projects. 

Major Duties and Responsibilities:

• Direct/Oversee the design and implementation of early stage clinical projects, as a member of the clinical project team. Ensure that the overall scientific and medical content of all clinical programs is sound.
• Ensure the integration of pre-clinical and early clinical findings with planned clinical programs; work to secure cross functional alignment and/or transparent discussion of risks associated with clear plans to further investigate and track through clinical development.
• Support clinical team activities, and lead Study Teams and provide expertise and contributions to Clinical Project Teams, Study Teams, and Global Program Teams, which involves responsibilities ensuring delivery of the portfolio of early assets.
• Support or lead cross-functional ad-hoc workstream matrix teams comprised of multidisciplinary professionals and clinical scientists, which involves responsibilities ensuring delivery of specific tasks or input needed for efficient delivery of the portfolio of early assets.
• Direct and be responsible for the short and mid-range clinical research efforts and progress by executing clinical study projects and support information flow on key progress reports to senior directors and others assigned to the Project Team as well as Clinical Project and Study Teams on a global basis.
• Prepare clinical development plans and institute properly approved clinical protocols. Design scientifically rigorous and maximally cost-effective clinical development program for the desired indication(s).
• Present and defend study protocols. Implement clinical R&D policies, SOPs and related directives.
• Monitor study progress, leading the analyses and data evaluation and analysis process for progress-reporting and presentations to senior management.
• Prepare and deliver clinical content needed for various official and regulatory documents, such as Dossiers, NDAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex safety or efficacy issues.
• Serves as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I-II studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation.
• Working with Patient Safety, ensure that Serious Adverse Events are properly reported on a global basis.
• Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced business development opportunities.
• Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.

Requirements/Qualifications:

• Prior experience in clinical research design/implementation of protocols, review/interpretation of data is required. This could be obtained through prior work in the pharmaceutical industry, Regulatory, or academic clinical research.
• Must demonstrate knowledge of the clinical development process and have direct clinical research and experience. Knowledge of clinical trial management, data management, and drug development process.
• A detailed understanding of human disease, pharmacology, biochemical medicine and the relevance of pharmacodynamic/clinical endpoints that underlie the action of the drug(s) being developed.
• Must demonstrate up-to-date scientific knowledge in main area of clinical interest.
• Team leadership experience preferred.

Education:

• MD
• Medical specialty and sub-specialty (fellowship) training and certification are required within cardiovascular, renal and metabolic therapeutic areas or respiratory – or similar qualifications from pharma-industry.

Experience: 

• A fellowship or training in at least one of the therapeutic areas within cardiovascular, renal and metabolic therapeutic areas or respiratory. Clinical or research experience in field of specialization is highly desirable. 
• At least 2-5 years of experience in clinical research and/or drug development in pharmaceutical or CRO environment.

Special Skills/Abilities: 

• Excellent oral and written communication skills; strong interpersonal and listening skills.
• Results driven and able to achieve creative and sound outcomes.
• Aspirational leadership skills and demonstrated ability to interact collaboratively in a cross-functional and matrix organization environment.
• Ability to make sound and timely decisions; agile in learning and action oriented.
• High level of emotional intelligence; able to deal with ambiguity.

Able to relate to varied level audiences across organization; able to build and contribute to effective teams and coach & develop team members; able to set priorities for team and maintain accountability; experience managing and developing others.

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.