In collaboration with other Research and Development departments and applicable Business Unit partners,
• Responsible for the strategic and operational oversight, management, and delivery of a clinical development program or study in support of Shire's project strategy team.
• Authors, provides input, and/or oversees program and/or study level documents.
• Manages clinical outsourcing and may represent Clinical Programs on vendor oversight committees.
• Manages financial aspects of assigned clinical program or study(ies) and provides to Development Team Lead.
• Responsible for strategic initiatives for process and business improvements.
• Provides functional input into the clinical development plan that aligns with Business Unit and product strategy.
• Collaborates with project physician, statistician and relevant functional areas on clinical trial designs.
• Provides strategic clinical programs input to Global Development Team (GDT) and Product Strategy Team (PST) as required.
• Co-leads the Development Operations Team (DOT) with the Global Clinical Development Lead (GCDL).
• May attend advisory panel meetings and regulatory agency meetings related to strategy of program, indication, and studies.
• Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, promotional guidelines and labeling) to drive the clinical trial application process.
• Effectively represents the interests and perspectives of GCDO.
• Presents program/study(ies) overviews/status to senior management, cross functional team, and external partners as necessary.
• Co-leads inspection readiness activities, and acts as subject matter expert during regulatory inspections.
Oversees or is responsible for:
• Program and /or study level document generation (e.g., synopses, ICFs, submission modules).
• Vendor selection including critical review of contracts, and/or work orders and management of ongoing performance.
• Collaboration with internal functions to ensure successful implementation of program/study.
• Presentations at relevant internal and external meetings
• Conducting study level training.
• Alignment of program for cross functional team regarding execution.
• Reporting of program / study milestones including mitigation.
• May assess long-range resource needs and make recommendations and allocations across program(s).
• Mentors junior staff.
• May be involved in interviewing, hiring, and training employees.
• Provides feedback on employee performance.
• Promotes Clinical Programs achievements within and across department(s).
• Works closely with Global Development Team Lead (GDTL), finance business partner, and/or study team(s) to generate and review forecasts and accruals for clinical studies. • Ensures clinical program/study(ies) finances align with agreed development plan, and budget variances are escalated to management as appropriate.
• Reviews and contributes to strategy for operational efficiency.
• Collaborates on SOP development.
• Identifies or participates in innovative initiatives targeted to improve/revise clinical development processes.
• Ensures implementation and standardized use of Global Clinical Development Operations (GCDO) and/or other R&D tools.
Education & Experience Requirements
• Bachelor's degree or nursing qualification is required. Scientific/health care field preferred but not required. Advanced degree preferred.
• Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmceutical company or CRO
• Global clinical trial research experience
• Experience leading cross functional teams
• Detailed knowledge of current regulatory requirements and guidelines governing clinical research
• Participation in marketing application review and submission is preferred.
• Experience managing financial budgets is preferred.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.