Director Physician, Early Clinical Development AstraZenecaLocation: Gothenburg, Västra Götaland, Sweden
Job reference: R-016375
Posted date: Nov. 02, 2017
At AstraZeneca we win through science, it’s at the heart of our every success. That science is only possible when we all work together – we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do. We are now recruiting a Director Physician within Early Clinical Development.
Main Duties and Responsibilities
As Director Physician, you will work out of the Translational Medical Unit within the cardiovascular- and metabolic disease area (CVMD) in the Early Clinical Development organization reporting to the head of the unit. You will work in a matrix organization in close collaboration with the basic innovative medicine (iMED) CVMD research organization, providing the project team with the Medical Scientific strategies - including Line of Sight of the Clinical Development Plan. Core disease areas include diabetes, chronic kidney disease and heart failure. As “Medical Science Director” you have accountability for the overall clinical risk:benefit, scientific and value content and delivery of the Medical Science components of the project to time and quality. Furthermore, you will be responsible for the design, conduct, monitoring, data interpretation and reporting of individual clinical trials and ensure projects adhere to Good Clinical Practice (GCP) and regulatory requirements. You will also be responsible for acting as a renowned expert in own disease/drug field.
- Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and the product in compliance with GCP
- Designs or manages the implementation of the medical strategy within Clinical Development globally
- Develop clinical evidence for functional relevance of targets in human disease
- Support qualification of pharmacodynamic/disease markers for early assessment of efficacy
- Ensure that clinical input into the Translational Medicine and development strategies and plans receive adequate peer consultation to assure high scientific quality
- Maintains a high degree of understanding and awareness on new and emerging medical development
- Closely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans
- Writes the study synopsis
- Liaises with the internal and external medical community to follow developments within areas of expertise
- Medical Lead for regulatory communication and preparation of higher level documents
- Ensures internal and external peer review of potential study/programme design
- As available, provide clinical strategic input to in-licensing opportunities
- As available, line management responsibility for medical directors and medical scientists, delivering the performance management and guiding the professional development of direct reports
- Graduate of a recognized school of medicine with an M.D. degree or equivalent
- Specialty training or board eligibility
- Leadership experience
- >3 years clinical research expertise in relevant therapy area, in designing, monitoring and implementing clinical trials and interpreting trial results
- >3 years Drug Development Experience with a thorough understanding of pharmaceutical safety, reporting and surveillance processes
- > 3 years early clinical translational research expertise and experience, including experience in designing, monitoring, executing and interpreting clinical trials, with understanding of biomarkers, biostatistics and safety reporting
- Proven teamwork and collaboration skills
- Technical (medical and scientific) experience evaluating targets/agents for in -licensing or internal development
- Ability to travel nationally and internationally
- Organize and deliver Advisory Boards with international KOLs
- A clear demonstration of behaviours of: Truth seeking rather than success seeking, Agile responsiveness to scientific data, Embracing of peer review and Agnostic to internal-external sourcing
- MD, PhD or higher degree in scientific discipline
- Scientific publications track record in internationally recognized medical journals in the CVMD disease area
- Extensive general medical knowledge
- Experience in different organizations and geographic locations
If you are interested, apply now! For more information about the position please contact Allan Vaag at +46 730 838727.
Welcome with your application no later than November 26, 2017.
AstraZeneca is a global, innovation-driven biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. In addition to being one of the world's leading pharmaceutical companies, AstraZeneca is proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity. AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.