Shire Global Clinical Development Lead in Cambridge, Massachusetts
Global Clinical Development Lead - Hematology
As Global Clinical Development Lead, provide leadership and management of clinical development activities in the Hematology Therapeutic Area.
Lead development and execution of medical & clinical strategy for assigned Shire programs
Leadership of Clinical Sub-team of the LPT/EPT
Oversight of study design and data generated, including clinical trial medical monitoring, from Shire sponsored Phase 1-4 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
RESPONSIBILITIES AND REQUIREMENTS
Collaborates with Global Development Team Lead, Therapeutic Area Head, Clinical Operations, Biostatistics, Drug Safety, Regulatory Affairs, Medical Affairs and other functions as required, 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.
Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
Co-Leads 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 Clinical Development 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. May involve management of 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 1-4 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.
Interact with and support Commercial function, eg. in development of Target Product Profile
Ability to work effectively in cross-functional matrix organization
High analytical skills, especially with regard to understanding and interpreting medical/scientific data
EDUCATION & EXPERIENCE REQUIREMENTS
• M.D. degree (required); specialty training and certification (preferred)
• Minimal 5 years of experience in the Pharmaceutical Industry in relevant areas
• Demonstrated ability to collaborate in a matrixed environment
• Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities
• Experience in designing and conducting Phase 1-3 clinical trials
Notice to Employment / Recruitment Agents:
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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, 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.