Research Development Project Manager Jobs in Franklin, MA

TypicalAccountabilities

Develop and align strategies andobjectivesfor Clinical Research & Development, ensuring they support AstraZeneca's 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 practices,new 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 leadership,creativityand 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 (Master's, 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 AstraZeneca's 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