POSITION

SALARY

INDUSTRY

LOCATION

TYPE

REF #

Chief Operating Officer

open

Public Health

Toronto

Permanent

110601ME

POSITION DESCRIPTION

  • Responsible for managing business development, Finance, Phase I/II and BA/BE clinical trials

  • Identifies business opportunities and prioritize to fruition.

  • Oversee study protocols, study manuals, case report forms, and informed consent forms.

  • Oversee proposal solicitation, evaluation, selection, oversight monitoring clinical programs, Regulatory Affairs and Project Management

  • Ensures clinical site project manager communications between Lambda Canada and clinical site as well as with Global Lambda, Inc.  

  • Oversee standard operating procedures for clinical trial conduct and monitoring in collaboration with Regulatory Affairs and Quality

  • Manages external resources such as consultants or paid advisors

  • Other duties and responsibilities as assigned

  • Position requires travel as required to manage business development and clinical trials

REQUIREMENTS

  • Demonstrated ability to manage business development, Phase I/II  trials to ensure enrollment and proper trial conduct

  • MD, PhD, BS, RN, MS or PharmD degree plus at least 5- 10 years of experience in the biotechnology or pharmaceutical industry

  • Minimum of 5-10 yrs experience in CRO industry with more than 2 years as a Senior Executive or above  in a medical affairs function at a biotechnology or pharmaceutical company with direct involvement in early phase human clinical trials 

  • In-depth experience in CRO industry, critically evaluating competing proposals, negotiating key terms, and selecting/initiating these relationships

  • Experience in review or writing of clinical protocols, study manuals, case report forms, and informed consent forms 

  • Technical understanding of drug development is required

  • Experience in Dermatology and/or metabolic disease or narcotics is preferred

  • Ability to present technical and business aspects of projects

  • Forward-thinking and creative with high ethical standards

  • Team player with leadership skills 

  • Able to work in a fast paced environment with drug development professionals

  • Well organized and self-directed 

  • Strong interpersonal skills with ability to communication with all level employees