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 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
MD is required.
Three to five years experience in clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.
Demonstrated ability to collaborate in a matrix environment
Experience with interactions with Regulatory authorities.
Experience in designing and conducting Phase II-III clinical trials.
Key Skills and Competencies
Expertise in hematology and hemophilia management is preferred
Experience in rare diseases highly desired
Demonstrated in-depth understanding of drug development and pharmaceutical marketing within Therapeutic area.
Working knowledge of regulations relating to drug development and promotional activities
Demonstrated ability to communicate and plan effectively with other Shire departments and to respond to inquiries or complaints from customers.
Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences.
Strong management skills with demonstrated ability to plan for staffing needs, make hiring decisions, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individuals’ skills, talents and career interests which ensure development of a talent pool for the future. Ability to create and maintain and organizational structure that serves the needs of the business.
Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results.
Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization.
Strong business acumen preferred with the ability to shape corporate strategy using knowledge of the global pharmaceutical industry.
Ability to capitalize on business opportunities by developing well thought out strategies and initiatives.
Availability to travel approximately 25% of time.
Availability to participate in early or late meetings/teleconferences.
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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.
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.