AstraZeneca Pharmaceuticals LP Director Physician - Early Clinical Development in Gothenburg, Sweden
Placement: Gothenburg, Sweden
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
We are now looking to hire a Director Physician to our team at Gothenburg, Sweden.
AstraZeneca believes that the future is looking very exciting for the company – mainly due to a number of significant clinical catalysts and the overall potential of their drug development pipeline. Therefore, for the right person, the opportunities for personal growth are immense - you will be joining AstraZeneca at a time of growth and positive change and will be part of a department and company which is respected for its high calibre people, strong clinical and scientific acumen, innovation, commercial excellence and modern drug development.
You will work in an exciting environment and join a team of 17, including medically qualified physicians, medical scientists, clinical project leaders as well as study leaders. We have close links with the preclinical research organisation (RIA iMed) and provide clinical input and plans for all small molecules in the early development portfolio and work closely with translational science and personalised healthcare.
In your role as Director Physician you will report to the Vice President, Translational Medicine, RIA. The physician tale is a business-critical and influential role with high level accountabilities. You will be involved with the early clinical development of at least 2 compounds in the portfolio. You will get a unique experience of translational science interacting with clinical medicine. Our aim is to move treatment of Respiratory disease beyond symptom control to disease modification and cure - we have a number of assets in the pipeline so this is a very exciting time in Respiratory drug development at AZ.
As Director Physician you will deliver the Medical Scientific strategies of the Clinical Development Plan (CDP) to the project team, and will have accountability for the clinical risk/benefit, scientific and value content and delivery of the Medical Science components of the project to time & quality.
As Director Physician you will also be responsible for the design, conduct monitoring, data interpretation and reporting of individual clinical trials whilst ensuring projects adhere to Good Clinical Practice and regulatory requirements. You will also be an expert in their own disease/drug field.
You will have responsibility and accountability for delivering clinical work which establishes the platform of evidence in human which credentials the target linkage to human disease and find evidence that a pathway drives a disease and the phenotype of patients in whom these pathways are activated. In addition you will use their clinical/scientific acumen to maximise the efficient delivery of the highest quality clinical data in support of the ongoing strategy.
Main Duties and Responsibilities
Leader for the design 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
5 years clinical research expertise in relevant therapy area, in designing, monitoring and implementing clinical trials and interpreting trial results
Specialty training or board eligibility
Significant leadership experience
5 years Drug Development Experience with a thorough understanding of pharmaceutical safety, reporting and surveillance processes
At least 5 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
PhD in scientific discipline
Extensive general medical knowledge
Experience in several organizations and geographic locations
Clinical Pharmacology experienece
If you are interested, apply now!
Welcome with your application no later than June 11th, 2017.
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.