GMA Evidence Generation Operations Lead (Assoc. Director)応募 後で応募 求人ID R0011478 掲載日 09/03/2019 Location:Zurich, Switzerland
GMA EVIDENCE GENERATION OPERATIONS LEAD (Associate Director)
The objective and purpose of the Lead Evidence Generation Operations, position is as follows:
Supports the review, approval and reporting of Medical Affairs Research programs/projects (i.e. MACs, IIR, CCR) which may be local, regional or global.
Responsible for supporting and reporting of MA studies globally, regionally and locally, in accordance with all applicable internal legal and compliance policies.
Manage cross-functional team (internal and external) to ensure compliance with Takeda policies).
Directly interface and collaborate with internal MA, QA, PV, Regulatory, Legal and IP as it relates to global, regional and local MA research activities.
Number of direct reports: 2 FTEs + 1 consultant
MA research program, global, regional and LOC support as required may include (budget planning and management, drug supply management, study tracking and archiving, systems development, SOP development, and training).
Ensures alignment of MA studies, processes and systems with key partners including regional and local offices IP, Regulatory, Legal, OEC, IT, and Finance.
Coordinates with regional Pharmacovigilance and Regulatory Affairs leads to respond to external audits and requests from external regulatory bodies. Oversee and coordinate support for internal and external audits related to the MA Research program.
Provide strategic and functional input to the development of regional MA research plans and budgets in collaboration with MA Region heads, LOC medical leads, TA Medical Heads, alliance partners, and other internal Takeda stakeholders.
Supervise, direct, coach, and develop MA Research managers and region-based MA research personnel.
Oversee the tracking and communication of key outputs, performance metrics, and accomplishments related to GMA research. Oversee the appropriate disclosure of study related information in accordance with compliance regulations.
Dimensions & Aspects:
Interaction: Aware of the changing external and internal environment and leads others through change by supporting, inspiring and engaging workplace. Effectively represent Takeda with the ability to resolve conflict in a constructive manner
Ability to build strong partnerships with other interfacing Takeda functions
Innovation: Able to implement organizational change and continuous innovation
Complexity: Knowledge required across therapeutic areas, indications, and/or modalities
Masters of Science or higher degree with 8 years or bachelor degree with 12 years of research related experience in the healthcare, pharmaceutical or related industry.
Minimum of 2 years management experience.
Proven track record of strategic leadership, teamwork, innovation, program oversight and demonstrated ability to manage, lead and mentor individuals.
Demonstrated understanding of legal, compliance, and regulatory guidelines related to the conduct of a variety of types of research trials in the pharmaceutical industry.
Experience working in a global organization highly desirable.
Experience working in a matrixed environment highly desirable