Medical Director, Senior Patient Safety Physician, Cell Therapy - Oncology

Do you haveexpertisein, and passion for Patient SafetyinOncology? Would you like to apply yourexpertiseto provide medico-scientific and clinical strategic leadership in a company that followsthe scienceand turns ideas intoinnovativelife 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,developmentand commercialization of prescription medicines for some of the world’s most serious diseases.Weare more than one of the world’s leading pharmaceutical companies. Working with one of the broadestcell therapypipelinesin the industry offers the possibility toadvancethe most novelCell and Gene Therapy (CGT)technologiesat all development stagesacross multiple indications. It takes each of usto challengeour thinking to keep pushing our pipeline forward and shape the future ofcell and gene therapies.

As a Medical Director, Senior Patient Safety Physician, Cell Therapy,you will report to the Cell TherapyOncologyGlobal Safety Project Lead (GSPL).Youwill bea senior leader withintheCell TherapyPatient SafetyUnit (CTPSU)and play a keyrolebringing deepclinical understanding and judgement in benefit risk assessments for AstraZenecacell therapies in oncology. Youwillalso have a role in shaping the culture of the departmentand will act as a coach and mentor to more junior Patient Safety staff. You will ensureprocessesadhere to Good Clinical and Pharmacovigilance Practice and regulatory requirementsas well as AZ processes.

MainRoleResponsibilities:

• Providing strategic Patient Safety input toCGTdrug development programsas part of a global matrix teamwith high-quality contribution to Safety & Strategy Management Team (SSaMT) deliverables

• Responsible forsafety contribution to study designs and study concept delivery within their assignedstudy/program

• Collaboration withPSteam members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findingsincluding safety signalvalidation.

• Ensuring expert input tosafety-relevantelements ofstudydesign and interpretation, including efficient use ofdigital/artificialintelligence (AI)tools andmethodology(e.g.adverse eventvisualisationanddisproportionalityanalysis.

• Providing leadership to support project discussions with governance boards, including interactions with Patient Safety ReviewBoard.

• Leadingthe safety strategy for regulatory communication andprovideoversight of higher-level documents to support submission activitiesfor assigned studies/products.

• Leadingmedico-scientific contributions torisk management plans (RMPs)for assigned productsand toPeriodic Reports, including PBRERs, DSURs.

• Authoringand accountable for theSafety-related aspects of theTarget Product Profile (TPP) and internal Go/No-Go InvestmentDecisions(ID)for theCTG product throughout its lifecycle

• More broadly you are expected toparticipatein advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked torepresentPatient Safety in cross-functional discussions with internal and external partners.

• May berequiredto support in-licensing opportunities.

NecessaryCandidateRequirements:

• MedicalDegreeor equivalent.

• 3+ years of provenclinicalexperienceas a physician or academic clinician.

• Extensive experience inpharmacovigilance, withclear evidenceof delivering to a high standard.Understanding ofthe medico-legal aspects of pharmacovigilance.

• Detailed understanding of pharmaceutical safety, reporting,and surveillance processeswithstrong experience of Patient Safety relatedto clinical trials and marketed products in any relevant field such asPharmaceutical 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 leadershipexpertiseis Patient Safetyof complex drugprograms

• 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

• Proficiencywith both written and verbal communications

AdditionalPreferredExpertise:

• Research experience in the GCT field

• Medicalspecialty, or documented training, in oncologyand/or haemato-oncology

• 5+ years of provenclinicalexperience

• Oncology therapeutic areaexpertiseand commercial understanding

• Extensive general medical knowledge

• Able to work acrosstherapeutic areas (TAs)andfunctions

• Experienced in using AI tools 

• Basic and/or TranslationalResearch background, includingauthoringpeer reviewed publications

• Good knowledge of PV regulations in China, Australia, Japan, rest of Asia