The Global Development Scientist Director will provide scientific and clinical input to all aspects of late stage product development. This includes but is not limited to the delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of products in respiratory and immunology therapeutic area (TA) in late stage development. In this role the scientist will seek input from the appropriate functional professionals 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 Senior Group Director 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 partners with all aspects of scientific input, clinical data quality metrics and safety evaluation. In this particular role, in the COVID vaccine program, which is a high- impact, business critical, fast paced team, key will be submission work, data cleaning activities, last phase of a study and interactions with Health Authority as well as external committee meetings (DSMB.PSRT etc). You need to been able to demonstrate good skills in these particular areas.
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 late stage respiratory, immunology and infection 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 partners. 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 independently lead some activities while contributing to regulatory submissions, process improvement, and mentoring.
- 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.
- Late stage clinical development experience in Immunology, Allergy or Respiratory.
- 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 Phase III and/or Phase IIb clinical development and experience with regulatory submissions, life cycle management, advisory boards, annual safety updates.
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- Salary 30000-31000