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Providing leadership and management within CD to provide scientific and clinical development support for products within assigned therapy area.
Support development and execution of medical & clinical strategy for assigned Shire product(s).
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
Act on behalf of Medical Monitor (GCDL) leading the interpretation 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
Participation/contribution to cross-functional team meetings; Provide support or act as senior company representative interacting with external scientific leaders and/or Regulatory authorities.
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.
Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution
This position may be combined with the GCDL position when the program is limited in its scope and complexity
Collaborates with Global Development Team Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provides scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific and clinical development expertise and providing guidance in support of brands and product launches.
Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
May supervises a variable number of CD professional and administrative staff;; Responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems.
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.
Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs.
Leads 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.
Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
EDUCATION & EXPERIENCE REQUIREMENTS:
Bachelor s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
Significant experience (12+ 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 25% 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.
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.
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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.