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    Senior Medical Director, Principal Patient Safety Physician - Oncology

    Astrazeneca
    10+ years
    Not Disclosed
    Gaithersburg
    10 Dec. 17, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Medical Director, Principal Patient Safety Physician
    Location: Gaithersburg, MD (3 days on-site)
    Salary: $265,781 to $398,671 + Excellent Benefits

    Company Overview:
    At AstraZeneca, we are a global, science-led, patient-focused biopharmaceutical company committed to developing life-changing medicines. Our broad Oncology pipeline presents an exceptional opportunity to work on cutting-edge molecules across all stages of development. Join us in our mission to push the boundaries of science, shaping the future of healthcare and improving patient outcomes.

    Role Overview:
    As the Senior Medical Director, Principal Patient Safety Physician, you will leverage your deep clinical expertise and leadership abilities to shape the culture of the Patient Safety department. In this pivotal senior leadership role, you will ensure that all projects comply with Good Clinical and Pharmacovigilance Practices and regulatory requirements. You will mentor junior staff, lead cross-functional teams, and contribute to the development of safety strategies for drug development and post-marketing programs.

    Key Responsibilities:

    • Provide strategic input to drug development and post-marketing programs, ensuring patient safety is prioritized.
    • Lead safety surveillance activities, including preparing high-quality evaluation documents to describe safety findings.
    • Contribute expert input to the design and interpretation of safety studies using tools such as modeling and simulation.
    • Lead the safety strategy for regulatory communication and oversee submission activities.
    • Provide medico-scientific contributions to Risk Management Plans (RMPs), PBRERs, and DSURs for assigned products.
    • Support advisory discussions to develop safety strategies across other Patient Safety teams.
    • Represent Patient Safety in cross-functional discussions with both internal and external collaborators.

    Essential Qualifications and Experience:

    • Medical degree with clinical experience or academic background.
    • Extensive experience in Pharmacovigilance and safety management, particularly related to clinical trials and marketed products.
    • Strong leadership and strategic oversight of complex drug projects.
    • In-depth understanding of pharmaceutical safety, reporting, and surveillance processes.
    • Experience leading cross-functional teams and influencing key stakeholders.
    • Proven ability to communicate effectively, both written and verbally.

    Desirable Qualifications:

    • PhD in a scientific field.
    • Expertise in oncology or related therapeutic areas.
    • Ability to work across multiple therapeutic areas and functions.
    • Research experience with peer-reviewed publications.

    Why AstraZeneca?
    At AstraZeneca, we offer a Great Place to Work culture, empowering you to push the boundaries of science and unleash your entrepreneurial spirit. We foster diversity, collaboration, and lifelong learning in a mission-driven environment. Join us to make a meaningful difference in medicine, patients, and society.

    Compensation & Benefits:
    The annual base pay for this position ranges from $265,781 to $398,671, with additional benefits including short-term incentives, equity-based long-term incentives, health coverage (medical, dental, vision), paid time off, 401(k) retirement plan, and more.

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    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |