Clinical Research & Development Associate Director Myositis/Immunology

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.   

Qualifications and Skills

• Essential : 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 

• Desirable : 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 

Key Relationship to Reach Solutions

• Internal: Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate 

• External: External service providers; Investigators;  

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.