Senior Global Development Scientist Director
hace 7 meses
**Job Title: Senior Global Development Scientist Director**:
**Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA**:
As a Senior Global Development Scientist Director (SGDSD) you will independently 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 and of studies that further characterize the overall benefit and risk and value of Respiratory and Immunology products in late stage development. **This role ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete.**
In this role you will seek input from the appropriate functional experts and will coordinate these activities in support of clinical studies and programs.
The SGDSD works as a member of a diverse and motivated team of researchers spanning across multiple divisions of Biopharmaceutical Units. The objectives of this role are set by the Global Clinical Program Lead in agreement with Global Clinical Head(s). The role will have a special focus on late stage clinical trials within respiratory & immunology where this role will work in close collaboration with the study team physician with all aspects of scientific input, clinical data quality metrics and safety evaluation.
The Senior Global Development Scientist Director independently leads many activities and contributes to science stories, regulatory submissions, process improvement and mentoring scientists and physicians.
**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, Clinical Operations, and Early Development groups.
- Be involved primarily in Late Phase (Ph2b and Phase 3) clinical programs but will collaborate with clinical colleagues supporting Early Phase programs as well as Medical Affairs colleagues.
- Provide expert scientific data/analysis into the preparation of regulatory documents and interactions with regulatory authorities.
- Provide expert scientific analysis and interpretation of data from ongoing studies and from within 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 results and ensure a robust safety evaluation process within the clinical team.
- Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments.
- Participate in the preparation of scientific publications and present scientific results and study protocol to multidisciplinary teams and key partners.
- Develop and review different clinical documents such as protocols, informed consent, investigator’s brochure, study report, briefing books.
- Provide scientific input to TA standards
**Education, Skills and Experience Required**:
- Scientific doctoral level degree (e.g. PhD or PharmD), relevant clinical qualification, or other relevant university degree with extensive experience from Late Phase clinical development within the industry.
- Ten or more years of relevant pharmaceutical industry experience (multi-country clinical trials).
- Understanding of scientific and clinical issues related to the design and implementation of clinical trials and interpreting trial results.
- Demonstrated ability to work collaboratively in a cross-functional setting, particularly with patient safety, vendors, CRAs, site staff and clinical operations.
- Experience with regulatory submissions, LCM, advisory boards, annual safety updates.
- Experience with dermatology and/or rheumatologic therapeutic areas preferred.
**Employer of Choice**:
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and ignite your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society.
We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a strong benefits array of offerings.
When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and high-reaching world.
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