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Senior Medical Director, Principal Patient Safety Physician - Oncology

7+ years
Not Disclosed
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 - Oncology
Location: Luton, UK (3 days on-site)
Salary: Competitive + Excellent Benefits

Company Overview:
At AstraZeneca, we are a global, science-led, patient-focused biopharmaceutical company, dedicated to discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases. We are driven by the mission to push the boundaries of science and bring life-changing medicines to patients. Our expansive oncology pipeline presents a unique opportunity to work on novel molecules at every stage of development, where each of us challenges conventional thinking to move our pipeline forward.

Role Overview:
We are seeking an Senior Medical Director, Principal Patient Safety Physician to join our team and provide strategic clinical leadership in the field of patient safety. In this role, you will bring deep clinical understanding and judgment to benefit-risk assessments for AstraZeneca products, while shaping the culture of the Patient Safety department. You will work closely with internal and external stakeholders to ensure that all projects adhere to regulatory requirements and Good Clinical and Pharmacovigilance Practices (GCP).

Key Responsibilities:

  • Provide strategic, medico-scientific, and clinical leadership for assigned products, ensuring safety strategies are aligned with drug development and post-marketing programs.
  • Lead safety surveillance activities and prepare high-quality safety evaluation documents.
  • Support the design and interpretation of safety studies using tools and methodology like modeling and simulation.
  • Lead safety discussions with governance boards, including the Patient Safety Peer Review Committee.
  • Oversee the safety strategy for regulatory communications, including submissions.
  • Contribute to Risk Management Plans (RMPs) and other safety documents such as PBRERs and DSURs.
  • Actively participate in cross-functional discussions, providing input to safety strategy across teams.
  • Represent Patient Safety in discussions with external collaborators.

Essential Qualifications and Experience:

  • Medical degree with clinical experience or academic background.
  • Extensive experience in Pharmacovigilance, particularly in clinical trials and post-marketing safety.
  • Strong leadership experience in complex drug projects.
  • Detailed understanding of pharmaceutical safety, reporting, and surveillance processes.
  • Expertise in the medico-legal aspects of pharmacovigilance.
  • Proven ability to lead cross-functional teams and influence stakeholders.
  • Excellent communication skills, both written and verbal.

Desirable Qualifications:

  • PhD in a relevant scientific field.
  • Expertise in oncology or related therapeutic areas.
  • Experience working across multiple therapeutic areas and functions.
  • Strong research background, including peer-reviewed publications.

Why AstraZeneca?
At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. We foster an inclusive culture that champions diversity and collaboration and is committed to lifelong learning and development. Join us in our mission to pioneer the future of healthcare.