Responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.
Clinical leader of defined program level activities and/or a large, complex trial under the leadership of the Global Program Clinical Head.
Provide clinical leadership and medical strategic input for deliverables in the assigned project/program.
Drive execution of the section of the program in partnership with global line functions and regional/country medical associates.
Oversee/conduct medical and scientific review of trial data.
Support GPCH in ensuring overall safety of the molecule and program safety reporting.
Provide medical input into Clinical Development Plan and clinical trial package reviews.
Support interactions with external partners and internal stakeholders.
Ensure career development of Program Reports and clinical colleagues through performance management and mentoring.
Contribute to medical/scientific training and may serve as speaker for Global Clinical team.
Requirements
MD (or equivalent medical degree) required.
Training in nephrology preferred
Medical Board certification preferred.
4+ years Clinical practice experience (including residency) preferred
Possess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required
5+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IV
3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrixed environment
Showcase advanced knowledge of assigned therapeutic area
Demonstrate ability to establish strong scientific partnership with key partners
Need thorough knowledge of Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory/clinical development processes
People management experience preferred, especially at the global level