- 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 GCP guidelines as well as 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).
- 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, and 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 and/or components of clinical plans (including, but not limited to, the ICF, CRF, TFL Shells, and Safety Reports).
- 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
- Core member of the GST representing Clinical Development.
- Responsible for the clinical input into Feasibility Questionnaires and consulted on country and site selection
- 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.
- Contribute to development and delivery of investigator and monitor training.
- 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.
- Support the development of clinical components of regulatory submission documents for instances where marketing approval is warranted
- Contributes to development and delivery of the clinical study report
- Work cross functionally in the preparation of launch & branding materials and publications
- Required Medical degree.
- Industry or academic experience in drug development required, Oncology 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.
- 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 to meet GCP, ICH and all AZ quality standards.
- Demonstrates solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.
- Oncology clinical development experience in the Pharmaceutical industry.
- 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 (e.g LSPC, DRC, PRC) or external groups (e.g Investigator Meetings, IDMCs, Conferences Presentations)
- Emerging leadership skills with the ability to influence others and drive consensus building
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Global Development Medical Director, Late Development Oncology - Warsaw, Polska - AstraZeneca
Opis
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.
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. We have multiple indications and many high-quality molecules at all stages of development – but we see even more potential.
Late Development Oncology sits within our broader Oncology Research & Development organization. Working with one of the broadest and deepest Oncology pipelines in the industry offers the possibility to work on the most novel molecules at all development stages. It takes each of us challenging our thinking to keep pushing our pipeline forward and shape the future of Oncology. Late Development Oncology focusses on Phase II-III trials and across a range of cancer indications, including: Breast, Lung, GI, GU and GYN.
We are diligent and committed to our science-driven approach, with a sharp focus on outcomes. We play an important part on the Clinical Project Team (CPT), and Global Study Team (GST) working collaboratively and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.
Collaborating closely with the respective Medical Scientist counterpart, 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, reporting successfully on time, 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 tumour working groups or cross Therapy Areas, depending on the level of experience.
As a key team member, this position demands strong collaborative communication skills. Someone who can engage with and influence a diverse range of partners both within and external to AstraZeneca.
Responsibilities. what you will be doing:
Essential for the role:
Desirable for the role:
Next steps, if the role looks suitable please apply
Why AstraZeneca?
Here you'll have the opportunity to make a meaningful difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world's most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.
Date Posted
25-mar-2024Closing Date
30-kwi-2024
