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4314 AstraZeneca Pharmaceuticals LP Company
Clinical Research & Development Associate Director Myositis/Immunology
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What they do
A Director of Research and Development is responsible for overseeing their organization's research and development department(s). Responsible for ensuring that the organization meet their objectives for researching and developing new products or technologies and improve existing products.
$212,783 / year median in Maryland
+5% projected growth
Job Description
What You Will Do A leadership role combining scientific, commercial, and operational expertise to drive the successful development and delivery of novel therapeutics for patients with inflammatory myopathies and/or Sjogren's Disease and autoimmune diseases . Responsible for integrating research and development strategies, ensuring robust, commercially viable study designs and execution, and optimizing cross-functional collaboration from early research through to late-stage clinical development and lifecycle management. Accountabilities
- Integrate the research , clinical, scientific and commercial aspects of drug development to ensure successful, value creating product development, either by overseeing a team of clinical research professionals, or by supporting such a team as an expert in one or more areas of clinical research
- Design and oversee studies to assess both scientific and commercial viability of drugs and portfolios, interpreting results as team head or expert contributor.
- Maintain a continuous focus on both scientific rigor and commercial goals, ensuring products meet regulatory, market, and patient needs throughout their lifecycle.
- Plan, monitor, and manage the delivery of all clinical development study components, including protocol design and drafting , operational feasibility assessment, timelines, risk/contingency planning, and resource allocation.
- Provide strategic and operational input into global clinical development plans and ensures implementation of agreed processes, technologies, and best practices.
- Lead the selection and negotiation processes for CROs and external partners, ensuring timely , quality delivery to specified standards.
- Participate in steering committees, regulatory defense teams, and submission assemblies; coordinates and contributes to the preparation of submission documentation for regulatory authorities.
- Serve as a communication bridge between internal and external stakeholders, ensuring alignment and timely dissemination of critical project information throughout the product lifecycle.
- Champion and sustains a culture of courageous leadership, innovation, and collaboration; develops and mentors clinical research and development staff in support of professional growth and project excellence.
- Monitor team and project performance, provides constructive feedback, and ensure compliance with Safety, Health, Environment, and all other relevant internal or external standards and regulations.