Global Clinical Development Lead - Gastroenterology
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POST DATE 9/8/2016
END DATE 12/6/2016
JOB DESCRIPTIONJob Description
Providing leadership and management within CD to provide medical and scientific support for products within assigned therapy area.
Support development and execution of medical & clinical strategy for assigned Shire product(s).
Oversight of study design and data generated, including clinical trial medical monitoring, from Shire sponsored Phase I-IV clinical research programs ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met.
Provide primary medical leadership in execution of clinical trials
Partner with other Shire functions to communicate scientifically accurate information to external stakeholders, meeting appropriate legal and regulatory requirements.
Acting as a 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.
Co-chair of the safety review team for assigned products
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 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 & EXPERIENCE REQUIREMENTS:
M.D. degree or PhD required; specialty training in Gastroenterology preferred
Experience working in Gastroenterology is highly preferred with clinical trial experience in Inflammatory Bowel Disease
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
Experience in submissions of IND/CTX/NDA/BLA/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 at least 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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