Shire Global Clinical Development Lead in Cambridge, Massachusetts
Collaborates with Global Development 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 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.
Co-Leads in safety review committees and risk management activities as appropriate.
Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
Provides support to global publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
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. Can manage Junior-level Physicians.
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 Medical 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 medical accuracy.
Participates in drug safety surveillance for Development projects.
Provides credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
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 and Experience Requirements
M.D. degree (required); Hematology training and certification (preferred).
Experience working in rare diseases is highly preferred
Generally has at least eight (8) years of experience in the Pharmaceutical Industry with relevant industry experience.
Demonstrated ability to collaborate in a matrixed environment
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.
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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.