Clinical Research & Development Associate Director Myositis/Immunology

AstraZeneca•Gaithersburg, MD

1d•Remote

About The Position

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.

Requirements

Advanced degree (Master’s, PhD, or equivalent) in a scientific, medical, or health-related discipline related to inflammatory and autoimmune conditions, their biology and treatment, relevant scientific literature and clinical trials
Comprehensive knowledge of the drug development process
Demonstrated knowledge of AstraZeneca line and project management tools and processes
Good understanding of the therapeutic areas related to AZ products
Ability to understand integrated worldwide and regional delivery needs
Very good knowledge of oral and written communication in English
Ability to travel nationally and internationally

Nice To Haves

Ability to mentor, develop and educate staff
Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
Manages change with a positive approach and flexibility to the challenges of change for self, team and business. Sees change as an opportunity to improve performance and add value to the business
Ability to look for and champion more efficient and effective methods/processes of delivering Clinical Development focusing on key performance metrics around reliability, productivity, cost and quality
Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment
Integrity and high ethical standards

Responsibilities

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.