Late Clinical Development, Scientist

3 weeks ago

Mississauga, Canada AstraZeneca Full time

Within Late Development Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.

**What you’ll do**

The Global Development Scientist and counterpart Global Development Medical Directorwork collaboratively in the clinical aspects underpinning a clinical program. The Medical Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working harmoniously and cross functionally (in a matrix environment) with other CPT & GST members and partners like Study Management, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.

Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. As such, you will provide clinical/scientific 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). You 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.

This position demands strong collaborative communication skills and the individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice (GCP) and regulatory requirements.

**Other responsibilities include but are not limited to**:

- Work cross functionally within clinical product teams (CPT to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents.
- Develop relationships with appropriate consultants and key external experts (KEE), study sites, and utilize these relationships to obtain feedback on protocol design, as well as study training, study execution, interpretation of study results and inform recruitment strategies.
- Responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.
- Accountable for the clinical and scientific leadership and integrity of protocols, clinical study reports and/or components of clinical plans.
- Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols.
- Contributes to technical review of protocols with governance bodies such as DRC and PRC.
- Contributes to the development of Medical Oversight Plan (MOP), study level safety reviews and study-level medical monitoring activities.
- Responsible for the clinical and scientific input into a study and for the quality of the clinical data
- Contribute to advisory boards to ensure there is engagement with site specific KEEs to ensure robust study designs, recruitment strategies.
- Contributes to the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions seeking Go/No Go decisions.

**Essential for the role**
- Bachelor’s degree with focus on life sciences or equivalent
- Industry or academic experience in drug development
- Detailed knowledge of GCP and other regulations governing clinical research.
- 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.
- Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
- Ability to drive/contribute to protocol design, writing and implementation
- Demonstrates solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.

**Desirable for the role**
- Advanced or Ph.D. degree in life sciences
- Oncology experience
- Strong experience with regulatory submission and related activities
- Emerging leadership skills with the ability to influence others and drive consensus building
- Emerging communication & presentation skills to communicate scientific concepts/data clearly and crisply in team settings and in formal presentations to leadership committees both i

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