• Responsible for providing scientific support for the company's clinical research and product development initiatives under the direction of GCDL
• Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
• Provides clinical scientist input into all regulatory questions, runs ad hoc searches
• Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
• Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents, reports etc,
• Support GDTL/GCDL to provide scientific leadership in execution of clinical trials
• Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
• Serve as a resource to address medical questions or clarify issues arising during conduct of the study
• Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required.
• Assist in the review, analysis and reporting of clinical trial data
• Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
• Collaborates with Global Development Team Lead, and Global Clinical Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and consistent;
• Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
• Supports the GDTL or GCDL when participating in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
• Assist the GDTL/GCDL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
• Supports the GDTL/GCDL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs.
• Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
• Participates in drug safety surveillance for Development projects.
• Act on behalf of GCDL/GDTL leading the interpretation of trial data and development and review of clinical study documents, reports etc,
Education & Experience Requirements:
• Master's degree in scientfic/healthcare field or nursing qualification is required.. Advanced degree i.e. Pharm. D/M.D./Ph. D preferred.
• Significant experience (7-10 years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.
• Demonstrated ability to collaborate in a matrixed environment
• Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
• Experience in designing and conducting Phase II-III clinical trials; and/or
• Significant late-stage development research.
Other Job Requirements:
• Availability to travel approximately 20% of time.
• Availability to participate in early or late meetings/teleconferences.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
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.