Global Development Scientist

The Global Development Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field based liaisons, and site personnel.

The Global Development Scientist and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. This includes providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA).

The Global Development Scientist may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience. As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.

Responsibilities:

• Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.

• Assists in the implementation of protocols and interactions with vendors and CROs, working closely within cross functional team. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials). Assists in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites. Serves as contact with vendors and CROs regarding medical/clinical science issues.

• Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc and write any necessary queries to be communicated to sites to ensure data accuracy and completeness of the assigned study.

• Participate in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program. Ensure updates to safety information is shared with cross functional study team. Support review of safety narratives.

• Supports preparation of abstracts, manuscripts, publications and poster presentations of clinical study findings and results throughout the life cycle of the assigned study or product, as applicable. Supports medical affairs activities, payer and reimbursement activities.

• Assists with drafting assigned sections of clinical reports, dossiers and other documents.

• Support Data Management in the build of the CRF and all associated instructions and plans (e.g. CRF completion instructions and Data Review Plan). Technical Skills

• Basic understanding of drug development from molecule to market and demonstrates knowledge of scientific methodology in the design, conduct and description of clinical research, at a study level.

• Ability to understand, and contribute to the drafting of documents used throughout the clinical study lifecycle, such as site initiation materials, registration documents, protocols, and presentations. Demonstrates solid understanding of methodology in the design, conduct and interpretation of clinical research. Outstanding attention to detail and outstanding written communication skills.

• Serves as medical/clinical science representative on study team and collaborates cross-functionally on applicable deliverables during study life cycle (e.g the protocol, CRF, data listings, TLF, CSR etc.)

• Ability to analyse and summarize clinical results. Support creation of and review of clinical slides for internal and external meetings.

Minimum Requirements

• Required Life Sciences degree or equivalent

• PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience

• Industry or academic experience in drug development required.

• Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.

• Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.

• Ability to grow and maintain a high level of expertise in oncology therapeutic area.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.