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Oncology Clinical Development, Medical Director
hace 3 meses
This position may be based in the US (Gaithersburg, MD, New York City, Waltham, MA) Barcelona, Spain; Warsaw, Poland; or Mississauga, Canada.
These roles are not available as remote positions.About AstraZeneca and Oncology Research & Development
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases.
We are more than one of the world's leading pharmaceutical companies. Our ambition is to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity, and collaboration - we make bold decisions driven by patient outcomes.
Within the
Clinical Development teams in Oncology R&D, 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.
What you'll do
Medical Directors within our Early and Late Clinical Development teams are diligent and committed to our science-driven and patient-centric approach, with a sharp focus on improving clinical outcomes.
Team members work cross functionally in a matrix environment with team members including counterpart Development Scientists, Clinical Operations and Data teams, Regulatory, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.
The Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product.Accountabilities include clinical support for the development and implementation of AstraZeneca sponsored clinical program strategies, including 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 (s)NDA/(s)BLA). The Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients.The Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-tumor working groups.
Responsibilities include:
- Responsible for the ensuring the riskbenefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safety
- 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
- Significant contributor to the development of program strategy for assigned compound(s)/programs and work with GPT/CPT members to develop a compelling business case for governance approval
- Provide expert clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives
- Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
- Provides expert input into/lead the development of the protocol and related documents and the development and delivery of the clinical study report
Essential for the role
- Required M.D degree or equivalent. 2 years of relevant experience.
- Strong preference for individuals with clinical training in oncology
- Industry or academic experience in drug development is required with significant oncology therapeutic experience.
- 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.
- Drug Development/
Clinical Development Planning:
Demonstrates a proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plan
