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Medical Director, Senior Patient Safety Physician, Cell Therapy
hace 2 semanas
**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. Working with one of the broadest cell therapy pipelines in the industry offers the possibility to advance the most novel Cell and Gene Therapy (CGT) technologies at all development stages across multiple indications. It takes each of us to challenge our thinking to keep pushing our pipeline forward and shape the future of cell and gene therapies.
As a **Medical Director, Senior Patient Safety Physician**, Cell Therapy**, you will report to the Cell Therapy Oncology Global Safety Project Lead (GSPL). You will be a senior leader within the Cell Therapy Patient Safety Unit (CTPSU) and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca cell therapies in oncology. You will also have a role in shaping the culture of the department and will act as a coach and mentor to more junior Patient Safety staff. You will ensure processes adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements as well as AZ processes.
Main Role Responsibilities**:
- Providing strategic Patient Safety input to CGT drug development programs as part of a global matrix team with high-quality contribution to Safety & Strategy Management Team (SSaMT) deliverables
- Responsible for safety contribution to study designs and study concept delivery within their assigned study/program
- Collaboration with PS team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings including safety signal validation.
- Ensuring expert input to safety-relevant elements of study design and interpretation, including efficient use of digital/ artificial intelligence (AI) tools and methodology (e.g. adverse event visualisation and disproportionality analysis.
- Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Review Board.
- Leading the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities for assigned studies/products.
- Leading medico-scientific contributions to risk management plans (RMPs) for assigned products and to Periodic Reports, including PBRERs, DSURs.
- Authoring and accountable for the Safety-related aspects of the Target Product Profile (TPP) and internal Go/No-Go Investment Decisions (ID) for the CTG product throughout its lifecycle
- More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external partners.
- May be required to support in-licensing opportunities.
- Medical Degree or equivalent.
- 3+ years of proven clinical experience as a physician or academic clinician.
- Extensive experience in pharmacovigilance, with clear evidence of delivering to a high standard. Understanding of the medico-legal aspects of pharmacovigilance.
- Detailed understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience of Patient Safety related to clinical trials and marketed products in any relevant field such as Pharmaceutical Industry, Regulatory Agency, or Public Health agency
- Experience in designing, overseeing, and implementing clinical studies with a focus on patient safety, including adverse event monitoring, safety data review, signal detection and evaluation, and interpretation of trial results to inform benefit-risk assessments and safety labeling.
- Documentable strategic leadership expertise is Patient Safety of complex drug programs
- Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making.
- Demonstrated ability to influence key business partners within and outside of company
- Proficiency with both written and verbal communications
Additional Preferred Expertise**:
- Research experience in the GCT field
- Medical specialty, or documented training, in oncology and/or haemato-oncology
- 5+ years of proven clinical experience
- Oncology therapeutic area expertise and commercial understanding
- Extensive general medical knowledge
- Able to work across therapeutic areas (TAs) and functions
- Experienced in using AI tools
- Basic and/or Translational Research background, including authoring peer reviewed publications
- Good knowledge of PV regulations in China, Australia, Japan, rest of Asia
**Why AstraZeneca?**
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place
