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Global Development Medical Director, Hematology Oncology

AstraZeneca

Overview Job Title: Global Development Medical Director, Hematology Location: Boston, MA Hybrid Role: Office based minimum 3 days per week 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 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 hematological cancers, we are motivated by a dedication to 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 and implementation of clinical trials, their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA). The Global Development Medical Director plays a critical role in the medical monitoring of a clinical study, ensuring safety to patients. They share responsibility with the Clinical Operations team members in the planning, execution and closure of a clinical study. The Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and contribute to cross-asset, cross-indication working groups depending on the level of experience. This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements. Responsibilities Responsible for ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safety. Work cross-functionally and lead all aspects of the design and implementation of clinical hematology-oncology projects, as a leader of the Clinical Product Team (CPT) and member of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous. Significant contributor to the development of program strategy for assigned compounds/programs and work with GPT/CPT members to develop a compelling business case for governance approval. Provide expert clinical input to influence the study design via collaboration with primary investigators, external experts, study sites, team members, and internal stakeholders, reflecting clinical practice, evolving landscape, regulatory and reimbursement requirements, and meeting program objectives. Participate or lead, as needed, the review and assessment of new opportunities and ESRs. Accountable for the relevance and accuracy of the clinical science underpinning the clinical study, for the clinical and scientific leadership and integrity of protocols and components of clinical plans, and for delivering final protocols and governance approval. Provide input into/lead the development of the protocol and related documents and the development and delivery of the clinical study report. Full responsibility for the planning, implementation and daily operation of assigned drug development projects in hematology-oncology. Support or lead interactions with global medical affairs, marketing, and commercial functions to ensure cross-functional input into protocols. Responsible for timely responses to investigational study sites for local ICF changes, protocol and EC/IRB questions; contribute to development and delivery of investigator and monitor training (face-to-face or virtual). Support the development of clinical components of regulatory and EC/IRB submission documents where marketing approval is warranted. Prepare clinical development plans that integrate pre-clinical and early clinical findings and maintain cross-functional alignment throughout early development. Present and defend protocols and clinical development plans at internal governance forums. Serve as Medical Monitor, responsible for safety monitoring of clinical trials, and as medical expert for Phase I/II or Phase III studies, driving improvement from protocol development to study report and regulatory documentation. Prepare regulatory documents such as Dossiers, BLAs, INDs, safety and annual reports, and manage responses to regulatory questions on complex development issues. Implement clinical R&D policies, SOPs and directives, and contribute to departmental initiatives to improve quality and cross-functional processes. Qualifications MD or international equivalent is required Minimum of 2 years of relevant experience Medical hematology-oncology clinical training is required Board Certification is preferred Clinical or research experience in oncology and/or malignant hematology in design and/or conduct of clinical studies is preferred General knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research General knowledge of medical monitoring; regulatory approval processes; pharmaceutical R&D operations; and marketing and commercial fundamentals Strong understanding of clinical trials methodology Strong communication and presentation skills to convey scientific concepts/data to leadership committees internally or externally Working at AstraZeneca Here you’ll have the chance to create a substantial difference to patients’ lives. With science at its heart, this is where breakthroughs born in the lab become transformative medicines for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem. Next Steps Apply now. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with a wide range of perspectives. We comply with all applicable laws and regulations on non-discrimination in employment and work authorization requirements. If you have a disability or special needs, please indicate accommodation needs in the application. Find Out More And Follow AstraZeneca On LinkedIn: Facebook: Instagram: Note: The annual base pay ranges from $241,613 to $362,420. Eligibility for incentive programs and benefits is as described in company policy and the offer letter. Date Posted: 25-Jun-2026 Closing Date: 26-Jul-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca

Vacancy posted 1 day ago
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