Global Development Medical Director, Hematology Oncology

About the role

The Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.

Responsibilities

• Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as 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 our Clinical Product Team (CPT) and member of the Clinical Sub-Team (CST). Ensure 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 work with GPT/CPT members to develop a compelling business case for governance approval
• Provide 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.
• Participate or lead 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.
• Provides expert input into/lead 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.
• Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
• 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 thorough 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, handling of 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.

Requirements

• MD or international equivalent is required
• Minimum of 2 years of relevant experience
• Medical hemato-oncology clinical training is required
• 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
• 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