Global Development Medical Director, Hematology Oncology

AstraZeneca • Gaithersburg, MD

5d • Hybrid

About The Position

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to the discovery, development, and commercialization of life-changing medicines for serious diseases. Within Hematology R&D, the company is committed to advancing science to deliver treatments for hematological cancers, utilizing a combination-focused pipeline across six scientific platforms. This unit oversees the value chain from discovery to late-stage development. The Global Development Medical Director is a key member of the Clinical Project Team (CPT) and Global Study Team (GST), collaborating cross-functionally in a matrix environment. They work with various teams including Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The role involves providing clinical support for the development and implementation of early and/or late-phase clinical program strategies, including trial design, delivery, data review, interpretation, reporting, and activities for worldwide registration. A critical aspect of the role is medical monitoring to ensure patient safety, sharing responsibility with Clinical Operations for study planning, execution, and closure. Depending on experience, the individual may also lead functional process improvement initiatives and contribute to cross-asset, cross-indication working groups. The position requires strong collaborative communication skills to engage diverse stakeholders and adherence to the highest ethical standards, Good Clinical Practice (GCP), and regulatory requirements.

Requirements

• MD or international equivalent is required
• Minimum of 2 years of relevant experience
• Medical hemato-oncology clinical training is required
• Possesses general knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
• Possesses general knowledge of 1) medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
• Good understanding of clinical trials methodology
• Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally

Nice To Haves

• Board Certification is preferred
• Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or malignant hematology is preferred

Responsibilities

• Ensuring the risk-benefit of a clinical study, and that all clinical studies operate to the highest ethical and safety standards in compliance with FDA, EMEA, ICH, and GCP guidelines as well as AZ SOPs regarding safety.
• Working cross-functionally and leading all aspects of the design and implementation of clinical hemato-oncology projects as a leader of the Clinical Product Team (CPT) and member of the Clinical Sub-Team (CST).
• Ensuring the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
• Contributing significantly to the development of program strategy for assigned compound(s)/programs and working with GPT/CPT members to develop a compelling business case for governance approval.
• Providing expert clinical input to influence study design through collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders.
• Participating or leading the review and assessment of new opportunities and ESRs.
• Being accountable for the relevance and accuracy of clinical science underpinning clinical studies based on detailed scientific review and consultation.
• Providing clinical and scientific leadership and integrity for protocols and/or components of clinical plans, and for the delivery of the final protocol and its governance approval.
• Providing expert input into/leading the development of the protocol and related documents and the development and delivery of the clinical study report.
• Having full responsibility for the planning, implementation, and daily operation of assigned drug development projects in hemato-oncology.
• Supporting or leading interactions with global medical affairs, marketing companies, and commercial teams, in collaboration with GCH/GCPL, to ensure cross-functional input into protocols.
• Responding in a timely manner to investigational study sites for local ICF changes, protocol, and EC/IRB questions/requests.
• Contributing to the development and delivery of face-to-face or virtual investigator and monitor training.
• Supporting the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted.
• Preparing clinical development plans that integrate pre-clinical and early clinical findings while ensuring cross-functional alignment throughout the early phases of clinical development.
• Presenting and defending protocols and clinical development plans at internal governance forums.
• Serving as Medical Monitor, responsible for the safety monitoring of clinical trials, and as a medical expert for Phase I/II or Phase III studies, innovating the process from protocol development through individual study report and coordinated regulatory documentation.
• Preparing various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, and handling responses to regulatory agencies regarding questions about complex clinical development issues.
• Implementing clinical R&D policies, SOPs, and related directives.
• Contributing to and supporting Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross-functional/organizational processes designed to effectively deliver the R&D portfolio.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• commission payment eligibility
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

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