AstraZeneca
Biopharmaceutical
GlobalDevelopmentMedicalDirector,HematologyOncology
Neural analysis suggests this role is
optimal for Director candidates.
“Global Development Medical Director, Hematology Oncology at AstraZeneca. Skills: Hematology Oncology, Clinical development, Drug development, Medical monitoring. Ensure risk-benefit of clinical study. Ensure clinical studies operate to highest ethical standards”
What You'll Achieve.
Deliver life-changing medicines; Advance the science; Accelerate promising assets; Life-cycle management programs; Worldwide registration of the product; Ensure safety to patients; Reporting successfully on time
Industry & Context.
Risk-benefit assessment; Scientific review; Data review; Interpretation of results
What They're Looking For.
Must Have
Clinical support for development and implementation of strategies, Clinical input into design and implementation of clinical trials, Clinical data review and interpretation, Reporting on clinical trial results, Activities for worldwide registration of the product, Medical monitoring of a clinical study, Ensuring safety to patients, Planning, execution and closure of a clinical study, Highest ethical and safety standards, Compliance with FDA, EMEA, ICH and GCP guidelines, Compliance with AZ SOPs regarding safety, Scientific and medical content of clinical programs, Development of program strategy, Business case for governance approval, Influence study design, Review and assessment of new opportunities and ESRs, Relevance and accuracy of clinical science, Clinical and scientific leadership and integrity of protocols, Delivery of final protocol and its governance approval, Development of the protocol and related documents, Development and delivery of the clinical study report, Planning, implementation and daily operation of drug development projects, Interactions with global medical affairs, Interactions with marketing companies, Interactions with commercial teams, Cross functional input into protocols, Timely responses to investigational study sites, Protocol & EC/IRB questions/requests, Development and delivery of investigator and monitor training, Clinical components of regulatory and EC/IRB submission documents, Development of clinical components for marketing approval, Prepare clinical development plans, Integrate pre-clinical and early clinical findings, Cross-functional alignment on early phases of clinical development, Defend protocols and clinical development plans, Medical expert for Phase I/II or Phase III studies, Innovating process from protocol development to study report
Nice to Have
Expert input or lead functional process improvement initiatives, Contributions to cross-asset, cross-indication working groups, Level of experience
What You'll Do.
Ensure risk-benefit of clinical study
Ensure clinical studies operate to highest ethical standards
Ensure clinical studies operate to highest safety standards
Ensure compliance with FDA guidelines
Ensure compliance with EMEA guidelines
Ensure compliance with ICH guidelines
Ensure compliance with GCP guidelines
Ensure compliance with AZ SOPs
Work cross-functionally
Lead design of clinical hemato-oncology projects
Lead implementation of clinical hemato-oncology projects
Ensure scientific content of clinical programs
Ensure medical content of clinical programs
Contribute to development of program strategy
Develop compelling business case
Provide expert clinical input
Influence study design
Collaborate with primary investigators
Collaborate with key external experts
Collaborate with study sites
Collaborate with team members
Collaborate with internal stakeholders
Participate in review of new opportunities
Lead review of new opportunities
Participate in assessment of new opportunities
Lead assessment of new opportunities
Ensure relevance of clinical science
Ensure accuracy of clinical science
Provide clinical leadership
Provide scientific leadership
Ensure integrity of protocols
Provide expert input into protocol development
Lead protocol development
Lead development of related documents
Lead development of clinical study report
Lead delivery of clinical study report
Take full responsibility for planning drug development projects
Take full responsibility for implementation drug development projects
Take full responsibility for daily operation drug development
Support interactions with global medical affairs
Lead interactions with global medical affairs
Support interactions with marketing companies
Lead interactions with marketing companies
Support interactions with commercial teams
Lead interactions with commercial teams
Ensure cross functional input into protocols
Respond timely to investigational study sites
Address local ICF changes
Address protocol questions
Address EC/IRB questions
Contribute to development of investigator training
Deliver investigator training
Contribute to development of monitor training
Deliver monitor training
Support development of clinical components of regulatory submissions
Support development of clinical components of EC/IRB submissions
Prepare clinical development plans
Integrate pre-clinical findings
Integrate early clinical findings
Ensure cross-functional alignment
Present protocols at internal governance forums
Defend protocols at internal governance forums
Present clinical development plans at internal governance forums
Defend clinical development plans at internal governance forums
Serve as Medical Monitor
Be responsible for safety monitoring of clinical trials
Act as medical expert for Phase I/II studies
Act as medical expert for Phase III studies
Innovate process from protocol development
Innovate process through individual study report
Innovate process through coordinated regulatory documentation
How You'll Work.
Team & Collaboration
Clinical Project Team; Global Study Team; Cross functional teams; Matrix environment; Clinical Product Team; Clinical Sub-Team; Primary investigators; Key external experts; Study sites; Team members; Internal stakeholders; Global medical affairs; Marketing companies; Commercial teams; Investigator training; Monitor training
Communication Scope
Collaborative communication; Engage stakeholders; Influence stakeholders
Process & Methodology
Clinical trial management, Drug development projects
Full Job Description
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. AstraZeneca has a multifaceted environment that cultivates collaboration and innovation. We attract top minds, and we nurture and build talent. Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death. This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programs The Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product. Accountabilities include clinical support for the development and implementation of early and/or late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activitie
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