Associate Medical Director, Patient Safety Physician, Cell Therapy – China Programs

AstraZeneca • Gaithersburg, MD

2d • $132,874 - $199,310

About The Position

Do you have expertise in, and passion for Patient Safety in Oncology? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into innovative life changing medicines? Then AstraZeneca might be the one 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. 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 an Associate Medical Director, Patient Safety Physician, China Programs, you will be a leader within the Cell Therapy Patient Safety Unit (CTPSU) by bringing deep clinical understanding and harmonization in safety strategy and risk assessments for AstraZeneca cell therapy studies conducted in China. 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 (PS) staff. You will ensure processes adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements as well as AZ processes.

Requirements

• Medical Degree
• 2+ years of proven clinical experience.
• Good knowledge of PV regulations in China.
• Understanding of the medico-legal aspects of cell therapy development in China, including Investigator-Initiated Trials (ITTs).
• Understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience of Patient Safety related to clinical trials and marketed products in China, 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.
• Capacity to collaborate across an international matrixed environment and influence cross-functional leaders on decision-making.
• Ability to influence key business partners within and outside of company.
• Proficiency with both written and verbal communications.
• Experienced in using AI tools.

Nice To Haves

• Research experience in the GCT field.
• Medical specialty, or documented training, in oncology, immunology, and/or rare diseases.
• Experience in pharmacovigilance, with evidence of delivering to a high standard.
• Strategic leadership expertise in Cell Therapy Patient Safety.
• Cross-therapeutic area (TA) expertise and commercial understanding.
• Able to work across TAs and functions.
• Basic and/or Translational Research background, including authoring peer reviewed publications.

Responsibilities

• Providing strategic patient safety input to CGT drug development programs in China 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 Global and China PS team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings and 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 visualization and disproportionality analysis.
• Providing leadership to support project discussions with governance boards, including interactions with Global and China Patient Safety Review Board.
• Supporting the cell therapy 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.
• Co-authoring safety-related aspects of the Target Product Profile (TPP) and internal Go/No-Go Investment Decisions (ID).
• Will join advisory discussions to help Patient Safety teams develop their strategies and may represent Patient Safety in cross-functional meetings with both internal and external partners.
• May be required to support in-licensing opportunities.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree