Global Development Senior Medical Director, Hematology Oncology
About The Position
The Senior Global Development Medical Director is a member of the Clinical Project Team (CPT) and Global Study Team (GST), working cross-functionally in a matrix environment with clinical and study team members, Site Management & Monitoring, field-based liaisons, and site personnel. The role works closely with the Global Development Scientist on the clinical aspects of product development and supports the development and implementation of early- and/or late-phase AstraZeneca-sponsored clinical program strategies. This includes scientific input into trial design and implementation, clinical data review and interpretation, timely reporting, and activities supporting worldwide product registration. The position provides medical oversight and monitoring of clinical studies to help protect patient safety and ensure appropriate risk-benefit. The role shares responsibility with Clinical Operations for study planning, execution, and closure, and may lead process-improvement initiatives or contribute to cross-asset and cross-indication working groups. Depending on experience, the Senior Medical Director may mentor less experienced clinical team members and may directly manage physicians or scientists. The role requires collaborative communication and the ability to engage and influence internal and external stakeholders. Work must adhere to high ethical standards, company SOPs, local laws and regulations, Good Clinical Practice, and applicable regulatory requirements. The position is hybrid, with a minimum of three days per week in the office. It is posted in Boston, with consideration also given to candidates in Gaithersburg, South San Francisco, or Barcelona.
Requirements
- MD or international equivalent.
- Medical hemato-oncology clinical training.
- At least 4 years of relevant experience.
- Significant clinical research experience in an industry, academic, or CRO environment related to drug development and the design or conduct of oncology and/or malignant hematology clinical studies.
- Detailed 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.
- Demonstrated ability to independently complete and lead peers in completing components of complex drug-development or clinical-development plans, related documents, methodologies, measures, analytical plans, and evaluation tools.
- Strong communication and presentation skills, including the ability to clearly communicate scientific concepts and data to internal and external leadership committees.
Nice To Haves
- Board certification.
Responsibilities
- Ensure clinical studies have an appropriate risk-benefit profile and operate to high ethical and patient-safety standards, in compliance with FDA, EMEA, ICH, GCP, and AstraZeneca SOPs.
- Lead cross-functional design and implementation of clinical hemato-oncology projects as leader of the Clinical Product Team and member of the Clinical Sub-Team; ensure clinical programs are scientifically and medically rigorous.
- Contribute significantly to strategy development for assigned compounds and programs and work with GPT/CPT members to build business cases for governance approval.
- Provide expert clinical input into study design in collaboration with investigators, key external experts, study sites, team members, and internal stakeholders, taking account of clinical practice, the evolving landscape, regulatory and reimbursement requirements, and program objectives.
- Participate in or lead reviews and assessments of new opportunities and investigator-sponsored research (ESRs).
- Ensure the clinical-science basis of studies is relevant and accurate, 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 oversee the daily operation of assigned hemato-oncology drug-development projects.
- Support or lead interactions with global medical affairs, marketing companies, and commercial teams, collaborating 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 the development and delivery of in-person or virtual investigator and monitor training.
- Support development of clinical components of regulatory and EC/IRB submission documents where marketing approval is sought.
- Prepare clinical development plans integrating 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, overseeing trial safety and supporting work from protocol development through study reporting and coordinated regulatory documentation.
- Prepare regulatory and official documents, including dossiers, BLAs, INDs, safety reports, and annual reports, and respond to agency questions about complex clinical-development issues such as safety or efficacy.
- Implement clinical R&D policies, SOPs, and related directives.
- Review potential in-licensing candidates and present recommendations to senior management.
- Support due diligence and prepare or present medically sound strategies and plans for advanced opportunities.
- Contribute to departmental and clinical initiatives that improve clinical-program quality and cross-functional processes for R&D portfolio delivery.
- Mentor less experienced staff, including physicians or scientists.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
