Global Development Senior Medical Director, Hematology Oncology

AstraZeneca • Gaithersburg, MD

1d • Hybrid

About The Position

This Senior Medical Director role is within the Hematology R&D unit at AstraZeneca, a global biopharmaceutical company focused on discovering, developing, and commercializing medicines for serious diseases. The unit is committed to advancing science in hematological cancers through a combination-focused pipeline utilizing six scientific platforms. The role is part of the Clinical Project Team (CPT) and Global Study Team (GST), working cross-functionally in a matrix environment. The Senior Global Development Medical Director collaborates with a counterpart Global Development Scientist on the clinical aspects of a product. Key responsibilities include providing clinical support for early and late-phase clinical program strategies, contributing to clinical trial design and implementation, reviewing clinical data, interpreting results, ensuring timely reporting, and supporting worldwide registration activities. 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 role may also involve leading process improvement initiatives and contributing to cross-asset/indication working groups. The position requires strong collaborative communication skills to engage diverse stakeholders and adherence to ethical standards, Good Clinical Practice, and regulatory requirements. Experienced individuals may mentor junior team members or manage other physicians/scientists.

Requirements

• MD or international equivalent is required
• Medical hemato-oncology clinical training is required
• Minimum of 4 years of relevant experience
• Significant clinical research experience (in industry, academic or CRO environment) related to drug development, design and/or conduct of clinical studies in oncology and/or malignant hematology is required.
• Possesses detailed 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.
• Demonstrates a proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.
• Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally

Nice To Haves

• Board Certification is preferred

Responsibilities

• Ensuring the risk-benefit of a clinical study, and that all clinical 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.
• Working cross-functionally and leading 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).
• Ensuring that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
• Significant contributor 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 the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.
• Participating or leading as needed the review and assessment of new opportunities and ESRs.
• Accountable for the relevance and accuracy of clinical science underpinning of 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.
• Providing expert input into/leading the development of the protocol and related documents and the development and delivery of the clinical study report.
• 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, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
• Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
• Contributing to 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 working to ensure cross-functional alignment on an ongoing basis 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 medical expert for Phase I/II or Phase III studies, innovating the process from protocol development thorough 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, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
• Implementing clinical R&D policies, SOPs and related directives.
• Reviewing potential in-licensing candidates and presenting recommendations to Senior Management groups.
• Supporting any needed due diligence and preparing/presenting medically sound strategy and plans associated with advanced opportunities.
• Contributing and supporting 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.
• Serving as mentor of less experienced staff that may include physicians or scientists.

Benefits

• 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