Sr. Global Development Medical Director (GYN)
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 a Sr. Global Development Medical Director (GYN) , we are diligent and committed to our science-driven and patient-centric approach, with a sharp focus on improving clinical outcomes. We are integral members of the Clinical Project Team (CPT) and Global Study Team (GST), working collaboratively and cross-functionally (in a matrix environment) with Site Management & Monitoring (SMM), field-based liaisons, and site personnel.
Collaborating closely with the respective Medical Scientist and Global Clinical Program Lead on the team, our accountabilities include clinical support for the development and implementation of late-phase AstraZeneca sponsored clinical program strategies, including providing input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA).
By joining our team, you will play a meaningful role in the medical monitoring, ensuring safety to patients. You will also share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study. Additionally, you 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.
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:
- Responsible for 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 Good Clinical Practice (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.
- 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 timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
- 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
- Required M.D. degree or equivalent. Strong preference for individuals with clinical training in oncology.
- Industry or academic experience in drug development required.
- Possesses detailed knowledge of 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.
- 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
- Ability to prepare and present clinical data and/or selected training sessions to internal/external groups.
- Ability to contribute to clinical reports and integrated summary reports
- Emerging communication & presentation skills including the ability to clearly communicate scientific concepts/data to leadership committees both internally and externally
- Emerging 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.
AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.
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 & 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.