Senior Global Development Medical Director (Late Oncology) - Lung
Senior Global Development Medical Director (Late Oncology) - Lung
Cambridge, UK / Warsaw, Poland
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Oncology Research & Development, Late Oncology
Join a dedicated Oncology team that’s growing fast and building a strong track record of success. We make bold moves at the cutting edge. Transforming molecules to change the practice of medicine.
In Late Development Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. The pioneers, we make bold moves that transform the way cancer is treated and truly improve patient outcomes.
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
As Senior 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 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 Senior Global Development Medical Director is 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 SOPs regarding safety.
The Senior Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide expert contributions to cross asset, cross tumor working groups or cross Therapy Areas, 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.
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.
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 (such as Global ICF, CRF, TFL shells, etc).
- Core member of the GST representing Clinical Development.
- 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 and/or components of clinical plans.
- Responsible for clinical leadership of study conduct
- May lead the development and approve the Medical Oversight Plan (MOP), lead study level safety reviews, and the study-level medical monitoring activities
- Responsible for the clinical input into Feasibility Questionnaires and consulted on country and site selection
- Contribute to development and delivery of investigator and monitor training.
- Assures oversight of collected data, monitoring safety and efficacy within a study.
- Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests
- Proactively engage with MSLs to build strong partnerships with SMMs and KEEs to provide robust feasibility assessments and streamline study execution
- Significant contributor to the development of program strategy for assigned compound(s)/programs including scientific contribution to the Target Product Profile and participation in the preparation of clinical development plans.
- In partnership with GCPL, and/or GCH drive work required for technical review of protocols with internal governance bodies.
- Work with GPT/CPT members to develop a compelling business case for governance approval.
- Participate or lead as needed the review and assessment of new opportunities and ESRs.
- Work cross functionally in the preparation of launch & branding materials and publications
- 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, inform recruitment strategies and meets the strategic program objectives.
- In partnership with the GCPL and/or GCH, lead the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions
- Lead development and delivery of the clinical study report and support the development of clinical components of regulatory submission documents for instances where marketing approval is warranted
- Support Health authority interactions as needed
- 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.
- Significant Industry or academic experience in drug development is required.
- 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.
- Significant oncology therapeutic experience to be sought out or serve as a resource to other internal/external parties.
- Maintains a high degree of understanding and awareness of new and emerging clinical developments to address impact on specific studies and clinical development plans.
- Shows leadership in the development of options for study design and development of the statistical analysis plan
- Possesses sound foundational knowledge of FDA and other major country regulations.
- Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
- Possesses strong 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 leverage state of the art methodology in the design, conduct, review and interpretation, and presentation of clinical research
- Can lead the development of content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents.
Desirable for the role
- Ability to prepare and present clinical data and/or selected training sessions to internal/external groups
- Ability to contribute to, and as needed, lead development of clinical reports and integrated summary reports for complex projects
- Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership governance committees and external groups (e.g Investigator Meetings, Independent Data Monitoring Committees, Conferences Presentations)
- Strong leadership skills with the ability to influence others and drive consensus building
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.