Senior Clinical Scientist
AstraZeneca / Biologjobb / Göteborg
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As a Senior Clinical 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, mechanistic studies, studies that further characterize the overall benefit, risk and value of Respiratory Therapeutic Area products. Also, in late stage development and other indications. The Senior Clinical Scientist ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete. In this role you would seek input from the appropriate functional experts and coordinates these activities in support of clinical studies and programs. The objectives 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 you 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 Science stories, regulatory submissions, process improvement and mentoring other scientists.
Typical accountabilities:
* 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
* Support and contribute to medical monitoring of trials
* Lead development of quality metrics and data review plan for assigned studies
* Develop and review protocols
* Renowned expert in own field. Works independently with guidance in only the most complex situations. May coordinate the activity of a research team and holds full accountability for projects, often with Global impact.
Essential Requirements:
* Scientific doctoral level degree (e.g. PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with extensive experience from clinical development.
* Eight 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.
Desirable Requirements:
* Demonstrated leadership experience and expertise in academia and/or the pharmaceutical industry
* Understanding of scientific issues related to the design and implementation of clinical trials and interpreting trial results
* Experience from registry studies, bioinformatics, artificial intelligence/machine learning or block chain activities
If you are interested, please apply now!
For more information about the position please contact Sami Daoud,
Welcome with your application no later than March 15th, 2019.
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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-02-21ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-03-07
Ange följande referens när du ansöker: R-045353
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
sara.jagevall@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4626532
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