Global Development Medical Director, Hematology Oncology

AstraZeneca • Cambridge, MA

1d • $241,613 - $362,420 • Hybrid

About The Position

AstraZeneca is seeking a Global Development Medical Director to support hematology-oncology drug development. The role is an important member of Clinical Project Teams (CPTs) and Global Study Teams (GSTs), working in a cross-functional matrix with colleagues across clinical development and operations, field-based liaisons, investigators, and clinical sites. The Medical Director partners with the Global Development Scientist on the clinical aspects of product development and supports early- and/or late-phase sponsored clinical programs, from trial strategy and design through delivery, data review and interpretation, reporting, and activities supporting worldwide product registration.

The role provides medical monitoring and is responsible for helping ensure patient safety and the risk-benefit profile of clinical studies. It shares responsibility with Clinical Operations for study planning, execution, and closure, and may lead process-improvement work or contribute to cross-asset and cross-indication initiatives. The Medical Director leads or contributes to the design and implementation of hemato-oncology projects, provides scientific and medical leadership for clinical programs, and helps ensure that protocols and study plans are scientifically rigorous and aligned with clinical practice, regulatory and reimbursement requirements, and program objectives.

The position is based in Boston, Massachusetts, and is hybrid, with a minimum of three office days per week. It requires strong communication and collaboration skills to engage and influence internal and external stakeholders, as well as adherence to ethical standards, company procedures, applicable laws and regulations, and Good Clinical Practice.

Requirements

• MD or international equivalent.
• At least 2 years of relevant experience.
• Medical hemato-oncology clinical training.
• General knowledge of Good Clinical Practice and other regulations governing clinical research.
• General knowledge of medical monitoring, regulatory approval processes in relevant countries, pharmaceutical industry and R&D operations, and marketing and commercial fundamentals.
• Good understanding of clinical-trial methodology.
• Strong communication and presentation skills, including the ability to communicate scientific concepts and data clearly to internal and external leadership committees.

Nice To Haves

• Board certification.
• Clinical or research experience in an academic, pharmaceutical, or CRO environment related to the design and/or conduct of oncology and/or malignant hematology clinical studies.

Responsibilities

• Ensure the risk-benefit of clinical studies and that studies meet high ethical and patient-safety standards and comply with FDA, EMEA, ICH, GCP, and AstraZeneca safety procedures.
• Work cross-functionally and lead the design and implementation of clinical hemato-oncology projects as a leader of the Clinical Product Team and member of the Clinical Sub-Team.
• Ensure the scientific and medical content of clinical programs is rigorous.
• Contribute significantly to program strategy for assigned compounds or programs and work with GPT/CPT members to develop business cases for governance approval.
• Provide clinical expertise to study design through collaboration with investigators, key external experts, study sites, team members, and internal stakeholders.
• Review and assess new opportunities and investigator-sponsored research submissions (ESRs), as needed.
• Ensure the clinical relevance and scientific accuracy of studies and provide clinical and scientific leadership for protocols and clinical plans through final protocol delivery and governance approval.
• Provide expert input into or lead development of protocols, related documents, and clinical study reports.
• Plan, implement, and manage the daily operation of assigned hemato-oncology drug development projects.
• Support or lead interactions with global medical affairs, marketing companies, and commercial teams, in collaboration with GCH/GCPL, to ensure cross-functional input into protocols.
• Respond promptly to study sites regarding local informed consent form changes and protocol or EC/IRB questions and requests.
• Contribute to face-to-face or virtual investigator and monitor training.
• Support development of clinical components of regulatory and EC/IRB submission documents when marketing approval is warranted.
• Prepare clinical development plans that integrate preclinical and early clinical findings and maintain cross-functional alignment during early clinical development.
• Present and defend protocols and clinical development plans at internal governance forums.
• Serve as Medical Monitor and medical expert for Phase I/II or Phase III studies, monitoring trial safety and contributing from protocol development through study reporting and coordinated regulatory documentation.
• Prepare regulatory documents, including dossiers, BLAs, INDs, safety reports, and annual reports, and respond to regulatory agency questions on complex clinical development issues.
• Implement clinical R&D policies, SOPs, and related directives.
• Support departmental and clinical initiatives to improve clinical program quality and cross-functional processes for delivering the R&D portfolio.

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.
• Short-term incentive bonus opportunity.
• Eligibility to participate in the equity-based long-term incentive program for salaried roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree