Global Development Scientist Director, Late R&i
2 weeks ago
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
The **Global Development Scientist Director** will provide scientific and clinical input to all aspects of late stage product development for respiratory assets. 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 products in respiratory therapeutic area (TA) in late stage development. In this role the scientist will seek input from the appropriate functional experts and will coordinate these activities in support of clinical studies and programs.
The Global Development Scientist Director ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete.
The objectives of the Global Development Scientist Director will be set by the Global Clinical Product Lead in agreement with Global Clinical Head(s).
The role will have a special focus on late stage clinical trials within the respiratory and immunology TA where the Global Development Scientist Director will work in close collaboration with the study team physician and other stakeholders with all aspects of scientific input, clinical data quality metrics and safety evaluation.
You will be expected to effectively collaborate with colleagues in the late stage respiratory and immunology 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 Biopharmaceuticals R&D.
The Global Development Scientist Director will lead independently some activities and contribute to regulatory submissions, process improvement, and mentoring.
**Typical Accountabilities**:
- Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
- 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.
- Present protocol and scientific results to multidisciplinary teams and key stakeholders.
- Develop and review protocols, informed consent, investigator’s brochure and other clinical development documents.
- Organize and analyse data from clinical research to build new hypothesis.
**Education, Qualifications, Skills and Experience**
**Essential**
- 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
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