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AstraZeneca

Global pharmaceutical company developing prescription medicines

Global Development Medical Director - Hematology Oncology

Biology & BiotechPosted on Sep 11
Full-timeGaithersburg, MD, USA

About the Job

Requirements

  • An MD or international equivalent is required.
  • A minimum of 2 years of relevant experience is required.
  • Medical hemato-oncology clinical training is required.
  • General knowledge of Good Clinical Practice and other regulations governing clinical research is required.
  • General knowledge of medical monitoring, regulatory approval processes in relevant countries, pharmaceutical industry and research and development operations, and marketing and commercial fundamentals is required.
  • A good understanding of clinical trials methodology is required.
  • Strong communication and presentation skills to clearly communicate scientific concepts and data to internal and external leadership committees are required.

Responsibilities

  • Ensure the risk-benefit profile of clinical studies and ensure they operate to high ethical and safety standards and comply with FDA, EMEA, ICH and Good Clinical Practice guidelines, as well as company safety standard operating procedures.
  • Work cross-functionally and lead the 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 have rigorous scientific and medical content.
  • Contribute significantly to program strategy for assigned compounds or programs and work with team members to develop a business case for governance approval.
  • Provide expert clinical input into study design in collaboration with primary investigators, key external experts, study sites, team members and internal stakeholders, reflecting clinical practice, evolving developments, regulatory and reimbursement requirements, and program objectives.
  • Participate in or lead the review and assessment of new opportunities and investigator-sponsored research.
  • Ensure the relevance and accuracy of the clinical science underpinning studies through scientific review and consultation; provide clinical and scientific leadership and integrity for protocols and clinical plans, and deliver final protocols for governance approval.
  • Provide expert input into or lead development of protocols and related documents, and develop and deliver clinical study reports.
  • Take full responsibility for 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 teams, collaborating with Global Clinical Head and Global Clinical Project Leader roles to ensure cross-functional input into protocols.
  • Respond promptly to investigational study sites on local informed consent form changes and protocol and ethics committee or institutional review board questions and requests; contribute to face-to-face or virtual investigator and monitor training.
  • Support development of clinical components of regulatory and ethics committee or institutional review board submission documents when marketing approval is warranted.
  • Prepare clinical development plans integrating preclinical and early clinical findings and maintain cross-functional alignment throughout early clinical development.
  • Present and defend protocols and clinical development plans at internal governance forums.
  • Serve as medical monitor responsible for clinical-trial safety monitoring and as medical expert for Phase I/II or Phase III studies, contributing from protocol development through study reporting and coordinated regulatory documentation.
  • Prepare regulatory documents for agencies, including dossiers, biologics license applications, investigational new drug applications, safety reports and annual reports; respond to agency questions about complex clinical development issues such as safety or efficacy.
  • Implement clinical research and development policies, standard operating procedures and related directives.
  • Contribute to and support departmental and clinical initiatives that improve the quality and content of clinical programs and cross-functional processes for delivering the research and development portfolio.

Desired Qualifications

  • Board certification is preferred.
  • Clinical or research experience in an academic, pharmaceutical or contract research organization environment related to the design or conduct of oncology or malignant hematology clinical studies is preferred.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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