Global Development Scientist Associate Director/Director

The Global Development 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 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. The Global Development Scientist ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete.

The Global Development Scientist would seek input from the appropriate functional experts and coordinates these activities in support of clinical studies and programs. The objectives of the Global Development Scientist will be set by the Senior Group Director in agreement with the Global Clinical Head(s). The role will have a special focus on late-stage clinical trials within the respiratory and immunology where the Global Development Scientist 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.

Typical Accountabilities

• Provide scientific contribution in the innovative design, execution and
• interpretation of clinical trials in one or more development programs.
• You will be involved primarily in late stage (Ph2b and later) clinical programs.
• Provide expert scientific input into the preparation of regulatory documents and
• interactions with regulatory authorities.
• 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.
• Present protocol and scientific results to multidisciplinary teams and key
• stakeholders
• Effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations, and early development groups.
• Provide expert scientific analysis and interpretation of data from ongoing studies and in the literature.
• Support and contribute to medical monitoring of trials.
• Lead development of quality metrics and data review plan for assigned studies.
• Develop and review protocols, informed consent, investigator’s brochure.
• Assist in planning for, and participate in investigator and coordinator meetings,
• representing the therapeutic area or region.

Education, Qualifications, Skills and Experience
Essential

• Science degree (e.g. MS, PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with experience from clinical development.
• Three or more years of relevant pharmaceutical industry experience (multicountry clinical trials) is required.
• Good understanding of design, execution and interpretation of clinical trials
• particularly in respiratory and immunology clinical development
• Good teamwork and collaboration skills