Global Development Scientist Director
hace 7 meses
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.
The role is based in Barcelona or Warsaw preferred.
**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 particularly in respiratory and immunology clinical development.
- Proven ability to work collaboratively in a cross-functional setting.
- Experience particularly in Phase II and Phase III clinical development.
**D**esirable**
- Experience with regulatory submissions, life cycle management, advisory boards, annual safety updates.
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