Director – Global External Research
The objective and purpose of the Director, Global External Research (GER) position is as follows:
- Responsible for the operations strategy, execution, and management of Global Medical Affairs studies in support of TA and product medical strategies and plans;
- Leads the overall process for planning, development, review, initiation, and conduct of Global Medical Affairs studies;
- Responsible for functional leadership and strategic partnerships with QA, PV, RA, and Global Development partners as it relates to the development and conduct of Global Medical Affairs studies;
- Oversee and manage GER headquarters staff and align the activities of regional and country GMA research related personal with GMA processes.
- Provide strategic input and functional expertise to support the development of GMA research plans and budgets;
- Collaborate with global, regional, and local Medical Directors to define operational strategy for GMA studies;
- Oversee the conduct of the GMA research program and ensure processes and studies are compliant with company policies and external laws and regulations;
- Serve as the lead for aligning GMA studies, processes and systems with key partners including TDC, TPC, IP, Regulatory, Legal, OEC, IT, and Finance. Represents GER in senior management forums;
- Provide central point of contact to region and local medical affairs personnel for research strategy, planning, issue management, and program execution;
- Oversee and coordinate the capture, archiving and reporting of appropriate patient safety information from GMA run clinical trials. Ensure coordination with Pharmacovigilance and Regulatory Affairs leads to respond to external audits and requests from external regulatory bodies;
- Responsible for global budget planning/forecasting and management for GMA studies;
- Escalates issues related to quality, timelines and budget and provides recommendations to upper management for resolution of these issues;
- Responsible for functional leadership in GMA, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of GMA research staff in a matrix environment;
- Oversee 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;
- Oversee and coordinate support for internal and external audits related to the GMA external research program.
EDUCATION, EXPERIENCE AND SKILLS:
- Doctoral degree in a health sciences related field with 7 years (or Masters of Science degree with 10 years or bachelor degree with 14 years) of research related experience in the healthcare, pharmaceutical or related industry;
- Minimum of 3 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 matrix environment highly desirable.