Global Development Scientist Director

As a **Global Development Scientist Director** (GDSD) you will independently provide scientific and clinical input to all aspects of late-stage product development. This includes 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. You will ensure that the safety evaluation process for the pivotal phase III trials is seamless and complete and will seek input from the appropriate functional experts and will coordinate these activities in support of clinical studies and programs.

The GDSD works as a member of a diverse and motivated team of researchers spanning across multiple divisions of Biopharmaceutical Units. This role will have a special focus on late-stage clinical trials within respiratory & immunology where you will work in close collaboration with the study team physician with all aspects of scientific input, clinical data quality metrics and safety evaluation. This role leads independently many activities and contributes to science stories, regulatory submissions, process improvement and mentoring other scientists and physicians.

**Role 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 tasked 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.
- 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 stakeholders.
- Lead development of quality metrics and data review plan for assigned studies.
- Develop and review different clinical documents such as protocols, informed consent, investigator’s brochure, study report, briefing books.
- Provide scientific input to TA standards.
- Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments.

**Education, Qualifications, Skills, and Experience**:

- Scientific doctoral level degree (e.g. PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with extensive experience from late stage clinical development.
- 10+ 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.
- Proven ability to work collaboratively in a cross-functional setting, particularly with patient safety, vendors, CRAs, site staff and clinical operations.
- Experience with regulatory submissions, life cycle management, advisory boards, annual safety updates.
- Experience with dermatology and/or rheumatologic therapeutic areas preferred.

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