Clinical Research & Development Director
Job Location:
Waltham, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
What You Will Do
Externally recognized as a thought leader with deepexpertisein both clinical research and developmentwith deep understanding of autoimmune disease specifically inflammatory myopathiesJIAand/or Sjogrens disease. Knowledge andexpertisein cell therapy is a plus.Drivethe integrated clinical research and development strategy and executionto ensurevalue creation and regulatory/market success through innovative cross-functional leadership. Operate independently and at scale influencing both operational excellence and strategic direction at the highest organizational levels.
TypicalAccountabilities
Develop and align strategies andobjectivesfor Clinical Research & Development ensuring they support AstraZenecas global goals and product vision.
Lead and overseeexecution and delivery of clinical research & development studies ensuring scientific rigor commercial viability and patient-centric focus throughout the drug lifecycle.
Lead the work with Line Managers toidentifyresource need and secure resources to ensure flexible andtimelyformation of the Clinical Research & Development Teams and progression of deliverables
Provide strategic and operational input to ensure implementation of best practicesnew technologies processes and global clinical strategies.
Manage resource planning in collaboration with line managers securing talent and flexible teams to support dynamic project requirements.
Oversee budgeting timelines contingency and risk management planning and escalate operational or strategic issues as appropriate.
Lead the negotiation and management of contracts with CROs and external service providers.
Drive the preparation review and delivery of regulatory submission materials and activelyparticipatesin regulatorydefense/approval processes.
Has personal responsibility for creating a culture of courageous leadershipcreativityand collaboration
Mentor develop and manage performance of line management and project teams ensuring alignment with organizational goals and fostering succession planning.
Ensure all work is compliant with internal and external standards including Safety Health Environment and regulatory guidelines.
QualificationsandSkills
Essential:Advanced degree (Masters PhD or equivalent) in a scientific medical or health-related discipline;Extensive experience in both clinical research and clinical development within the pharmaceutical or biotechnology industry;Familiarity with the scientific and clinical community;Proven leadership experience managing cross-functional and/or senior project teams;Demonstrated success in strategy development and execution in both clinical research and clinical development environments;Strong knowledge of the drug development process GCP/ICH guidelines and relevant regulatory requirements;Significant operational experience in the planning delivery and oversight of clinical trials and regulatory submissions;Budgetary resource and risk management expertise on a global or regional scale;Exceptional written and verbal communication skills and ability to present to diverse stakeholders;Demonstrated ability to mentor develop and lead teams;Highly skilled in stakeholder engagement negotiation strategic influencing and cross-functionalcollaboration;Commitment to compliance and safety health and environmental standards;Ability and willingness to travel nationally and internationally as required
Desirable:Experience as a recognized expert or thought leader within the business and wider industry;Project management certification or formal training;Experience in the introduction or implementation of new technologies or innovative approaches within clinical research or development;Experience in change management and process improvement initiatives;Experience managing complex organizational structures or leading in a global organizational context;Extensive familiarity with key therapeutic areas relevant to AstraZenecas portfolio;Record of effective succession planning and leadership development within multi-level teams;Experience in successful regulatory defense and participation in external advisory boards or similar expert panels;Advanced negotiation and contracting experience with CROs or external service providers;Ability to identify and leverage emerging trends in drug development technology and scientific innovation
Key Relationship toReachSolutions
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 SkillCentresas appropriate
External:External service providers;Investigators and scientists and patient advocacy groups; and external Alliance partners
Date Posted
25-Aug-2026Closing Date
10-Sep-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
Director
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
