Assist in the development, evaluation, planning and execution of clinical studies\n
Ensure scientific integrity and interpretation of study data of a clinical development program\n
Collaborate closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs\n
May contribute to candidate development projects through early and/or late phase development\n
Attend and actively participate in study team meetings\n
May contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings\n
Develops/maintains basic understanding of therapeutic disease area(s) and drug candidate\n
Apply basic scientific expertise to support execution of clinical research and development studies for early and/or late stage assets\n
Maintain compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety\n
Support clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety\n
Support identification of data trends and potential inconsistencies in data across assigned studies and raises issues as needed.

BS/MS/PhD/PharmD in a related area\n
≥ 6 years of pharmaceutical clinical drug development experience\n
Demonstrated basic knowledge of the drug development process, Good Clinical Practice, study design and clinical research methodology\n
beginner level medical writing skills\n
Strong management, interpersonal and problem-solving skills\n
Proven track record in clinical trial process improvements\n
Considerable organizational awareness, including significant experience working cross-functionally\n
Experience in one or more of the following therapeutic areas is preferred – cardiovascular, renal, metabolic disease\n
Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.

health and wellness programs (including medical, dental, vision, life, and disability insurance)\n
fitness centers\n
401(k) company match\n
family support benefits\n
equity awards\n
annual bonuses\n
paid time off\n
paid leaves (e.g., military and parental leave) for eligible employees at all levels!

Manager, Clinical Scientist – Internal Medicine, Cardio, Metabolic, Renal

Key skills