Global Clinical Team Lead - Hematology
* Drives clinical activities of one or more Programs including life cycle management (LCM) and co-leads the development operations team (DOT)
* In collaboration with the DOT, defines clinical strategy (clinical development plan, CDP) which is aligned with the Program strategy as defined by the global development team (GDT)
* Responsible for the benefit/risk clinical assessment, in collaboration with the safety review team (SRT); reports to GDT major safety issues and proposes adaptation accordingly; ensure together with PV leader the delivery of key safety documents (e.g., Risk Management Plan)
* Participates on the Global Medical Team as the GCDL
* Co-chair of the safety review team (SRT)
* 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.
* Collaborates with Global Development Team Lead, Therapeutic Area Head, R&D Business Unit Leaders, CDOB, International Medical Director and External Scientific 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 CDOB, 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 the development operations team (DOT)
* Co-Leads in safety review committees and risk management activities as appropriate.
* Assures conduct 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.