Global Development Medical Director (Breast Cancer)
Do you have expertise in Oncology clinical drug development and passion for developing late phase clinical program strategies? Would you like to apply your expertise to impact the way cancer is treated, and make a meaningful difference to patients, in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the place for you!
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.
Oncology Research & Development, Late Development Oncology
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 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
As Global Development Medical Directors, we are diligent and committed to our science-driven and patient-centric approach, with a sharp focus on improving clinical outcomes. The focus of this position will be breast cancer.
The Senior Global Development Medical Director 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 and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Senior 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 late phase 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 Senior Global Development Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. They share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study.
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 depending on the level of experience.
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.
Depending upon experience level, the role will mentor the development of less experienced members of the clinical team, and may involve direct line management of other physicians or scientists. The focus of this position will be breast cancer indications and portfolio. .
- Responsible for the ensuring the risk-benefit 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.
- Participate or lead as needed the review and assessment of new opportunities and ESRs.
- 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
- Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
- Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests. Contribute to development and delivery of face to face or virtual investigator and monitor training.
- Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted
- Serve as mentor of less experienced staff and may include the direct management of one or more staff
Essential for the role
- Required M.D degree or equivalent. Strong preference for individuals with clinical training in oncology.
- Industry or academic experience in drug development is required with oncology therapeutic experience, Breast cancer experience desired.
- 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 plans and evaluation tools.
- Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally
Desirable for the role
Ability to contribute to, and as needed, lead development of clinical reports and integrated summary reports for complex projects
- Maintains a high degree of understanding and awareness of new and emerging clinical developments to impact specific studies and clinical development plans.
- Strong leadership skills with the ability to influence others and drive consensus building
- Ability to contribute to, and as needed, lead development of clinical reports and integrated summary reports for complex projects
- Shows greater independence in the development of options for study design and development of the statistical analysis plan
With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.
So, what’s next
Are you ready to bring new ideas and fresh thinking to the table? Great! We have one seat available, and we hope it’s yours.
Where can I find out more
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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Competitive Salary and Benefits
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 authorisation and employment eligibility verification requirements.