Global Development Medical Director, Hematology Oncology

AstraZeneca • Gaithersburg, MD

5d • $241,613 - $362,420 • Hybrid

About The Position

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to the discovery, development, and commercialization of prescription medicines for serious diseases. Within Hematology R&D, the company is committed to advancing science to deliver life-changing medicines for patients in need. This unit focuses on a combination-focused pipeline across six scientific platforms to address unmet clinical needs in hematological cancers. The Global Development Medical Director is a key member of the Clinical Project Team (CPT) and Global Study Team (GST), collaborating cross-functionally with various internal and external stakeholders. The role involves providing clinical support for the development and implementation of 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. Experienced individuals may also lead process improvement initiatives and contribute to cross-asset working groups.

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 medical monitoring.
• Possesses general knowledge of the Regulatory approval process in relevant countries.
• Possesses general knowledge of pharmaceutical industry/R&D operations.
• Possesses general knowledge of 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

• Provide clinical support for the development and implementation of early and/or late phase AstraZeneca sponsored clinical program strategies.
• Provide clinical input into the design and implementation of clinical trials.
• Oversee the delivery of clinical trials, including clinical data review and interpretation of results.
• Ensure successful and timely reporting of clinical trial results.
• Contribute to activities required for worldwide registration of the product.
• Play a critical role in the medical monitoring of clinical studies, ensuring patient safety.
• Share responsibility with Clinical Operations team members in the planning, execution, and closure of clinical studies.
• Provide expert input or lead functional process improvement initiatives.
• Provide contributions to cross-asset, cross-indication working groups depending on experience level.
• Ensure the risk-benefit of a clinical study.
• Ensure all clinical studies operate to the highest ethical and safety standards and in compliance with FDA, EMEA, ICH, GCP guidelines, and AZ SOPs regarding safety.
• Work cross-functionally and lead 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).
• Ensure the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
• Be a 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 (KEE), study sites, team members, and internal stakeholders.
• Participate or lead as needed the review and assessment of new opportunities and ESRs.
• Be accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.
• Provide clinical and scientific leadership and integrity of protocols and/or components of clinical plans.
• Be accountable for the delivery of the final protocol and its governance approval.
• Provide expert input into/lead the development of the protocol and related documents and the development and delivery of the clinical study report.
• Have full responsibility for the planning, implementation, and daily operation of assigned drug development projects in hemato-oncology.
• Support or lead interactions with global medical affairs, marketing companies, and commercial, in collaboration with GCH/GCPL to ensure cross-functional input into protocols.
• Be responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
• Contribute to the development and delivery of face-to-face or virtual 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 various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports.
• Handle responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
• Implement clinical R&D policies, SOPs, and related directives.
• Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross-functional/organization processes designed to effectively deliver our R&D portfolio.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program (salaried roles)
• retirement contribution (hourly roles)
• commission payment eligibility (sales roles)
• 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