Under the direction of The Head of Medical Devices, Clinical Development the Device Global Clinical Development Lead will be responsible to serve as clinical representative on assigned device project teams and sub teams.
•Provide medical device expertise on assigned projects including strategy support as directed by the Head of Medical Devices
•Support safety assessments on combination product clinical programs.
•Ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met.
•Partner with other Shire functions to communicate scientifically accurate information to external stakeholders
•Review clinical protocols and clinical study reports ensuring accuracy of scientific and medical information.
• Support reviews and interpretation of clinical data to deliver meaningful efficacy and safety conclusions.
•Demonstrates the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
•Provides expert device development advice to assist the project teams for the development of clinical programs.
•Interacts as needed with Clinical Development partners such as Clinical Operations, Regulatory, Commercial and Compliance.
•Participate in clinical/medical advisory panels, steering committees and investigator meetings.
•Participates in safety review committees and risk management activities as appropriate.
•Assists in providing medical information support for marketed and developmental projects.
•Participates in drug safety surveillance for development projects.
•Provides support to publication strategy for assigned projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements.
•Remains up to date with current information on device regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
Education & Experience Requirements:
MD,DO or Pharm. D. required with at least 5 years of experience in drug or combination product development in the Pharmaceutical or Biotech industries or the equivalent in an academic research setting.
Experience in orphan drugs a plus but not required.
Ability to work cooperatively within a team setting is critical as are good interpersonal communication skills.
Must be able to effectively support a cross-functional team in a matrix organizational structure.
High analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
Must be capable of identifying, analyzing and adjusting work procedures for maximum efficiency and be able to meet tight deadlines.
Have knowledge of drug or combination product development strategies..
Will interact with the following functions:
Internal: Development project team members including representatives from regulatory affairs, research, clinical operations, biometrics, medical affairs and, occasionally manufacturing.
External: Key academic opinion leaders, representatives of regulatory agencies (such as the FDA and EMEA), CRO employees, clinical investigators.
Available 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 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.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.