Clinical Research & Development Associate Director Myositis/Immunology

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;