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Global Development Senior Medical Director, Hematology Oncology

$288.06k

AstraZeneca GmbH

Job Title: Global Development Senior Medical Director, Hematology Oncology Hybrid Working: In the office a minimum of 3 days per week Location: This Senior Medical Director role is posted in Gaithersburg, United States although we are willing to consider candidates in these Hematology locations: Boston, Massachusetts; South San Francisco, California; Barcelona, Spain. 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 a leading pharmaceutical company that cultivates collaboration, innovation and talent. Overview Within Hematology R&D, we are committed to advancing the science to deliver life‑changing medicines to patients most in need. Our pipeline exploits the power of six scientific platforms—Immuno‑Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody‑drug Conjugates, Cell Therapy and Epigenetics—to address unmet clinical needs in a host of hematological cancers. This unit has responsibility for the value chain from discovery through to late‑stage development. Responsibilities Ensure risk‑benefit of a clinical study, ensuring all 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 hemato‑oncology projects, as leader of our Clinical Product Team (CPT) and member of the Clinical Sub‑Team (CST). Ensure scientific and medical rigor of all clinical programs. Significant contributor to the development of program strategy for assigned compound(s)/programs and work with GPT/CPT members to develop a compelling business case for governance approval. Provide expert clinical input to influence study design via collaboration with primary investigators, key external experts, study sites, team members and internal stakeholders so that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets strategic program objectives. Participate or lead the review and assessment of new opportunities and ESRs. Accountable for the relevance and accuracy of clinical science underpinning the clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval. Provide expert input into or lead the development of the protocol and related documents and the development and delivery of the clinical study report. Full responsibility for planning, implementation and daily operation of assigned drug development projects in hemato‑oncology. Support or lead interactions with global medical affairs, marketing companies, commercial teams, in collaboration with GCH/GCPL to ensure cross‑functional input into protocols. Respond to investigational study sites for local ICF changes, protocol and EC/IRB questions/requests and contribute to the development and delivery of investigator and monitor training. Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted. Prepare clinical development plans that integrate pre‑clinical and early clinical findings while working to ensure cross‑functional alignment on an ongoing basis throughout the early phases of clinical development. Present and defend protocols and clinical development plans at internal governance forums. Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II or Phase III studies, innovating the process from protocol development through individual study report and coordinated regulatory documentation. Prepare official and regulatory documents for regulatory and other agencies, such as dossiers, BLAs, INDs, safety and annual reports, and handle responses to regulatory agencies regarding complex clinical development issues. Implement clinical R&D policies, SOPs and related directives. Review potential in‑licensing candidates and present recommendations to Senior Management groups. Support due diligence and prepare/present medically sound strategy and plans for advanced opportunities. Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs and cross‑functional processes. Serve as mentor of less experienced staff that may include physicians or scientists. Minimum Requirements MD or international equivalent is required. Medical hemato‑oncology clinical training is required. Minimum of 4 years of relevant experience. Board Certification is preferred. Significant clinical research experience (industry, academic or CRO) related to drug development, design and/or conduct of clinical studies in oncology and/or malignant hematology is required. Knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research. General knowledge of medical monitoring, regulatory approval process in relevant countries, pharmaceutical industry/R&D operations and marketing and commercial fundamentals. Demonstrated ability to independently complete and lead peers in the completion of complex plans, related documents, methodologies, measures, analytical plans and evaluation tools. Strong communication and presentation skills to clearly communicate scientific concepts and data to leadership committees both internally and 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 the place where breakthroughs born in the lab become transformative medicines. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem. Benefits and Compensation The annual base pay ranges from $288,059.20 - 432,088.80. Base pay may vary depending on factors such as location, job‑related knowledge, skills and experience. Short‑term incentive bonus, long‑term incentive program, retirement contribution (hourly roles) and commission payment eligibility (sales roles) are also included where applicable. Benefits include a qualified retirement program (401(k) plan), paid vacation and holidays, paid leaves and health benefits covering medical, prescription drug, dental and vision. Equal Employment Opportunity Statement 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, and harnessing industry‑leading skills. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment and work authorization and employment eligibility verification requirements. Date Posted 25‑Jun‑2026 Closing Date 05‑Jul‑2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca GmbH

Vacancy posted 2 days ago
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