Medical Scientist/ Clinical Project Lead (Exp With Clinical Trials & Good Clinical Practices)

Job Summary

Medical Scientist/ Clinical Project Lead (Exp With Clinical Trials & Good Clinical Practices)

About the Role

Responsible for setting work direction and completion of work tasks under supervision of the Medical and Scientific Affairs Manager. May provide input into product design on behalf of the Medical and Scientific Affairs team who are responsible for safety of product. Interacts with internal stakeholders such as Project Core Team members, Global Clinical Development, Statisticians, Regulatory Affairs, Marketing and Legal. May interact with key opinion leaders.

Responsibilities

• Must be knowledgeable about key aspects of simple to moderately complexity clinical studies to enable accurate inputs into Core Team product development plans.
• Responsible for liaising effectively with the Global Clinical Development Group (GCD) and across functions, in the execution of clinical studies supporting registration of BD products.
• Experience on budget and assessment of resources needs to provide the Project Manager/ Core Team leader(s) with the necessary information to conduct clinical studies and clinical research on behalf of the project.
• Recognizes existing problems, develops recommendations, and successfully implements solutions of simple or moderately complex problems.
• Represents Medical and Scientific Affairs (as part of team) on specific projects/programs. Interacts with clinical investigators and with Key Opinion Leaders.

Requirements for Success

• Industry experience, understanding of product development process and leverage support from cross functional team members.
• Excellent interpersonal and communication skills, including the ability to perform well in a highly matrixed environment, and as an effective member of a highly functioning multidisciplinary team
• Excellent written and verbal communication skills; demonstrated ability to create, organize and maintain technical/medical documentation supporting regulatory submissions, and communication of results (conferences, publications, etc.)
• Facilitates the creation of a bottom up/ top-down program schedule that gains the commitment of the program team and the Portfolio Decision Team, then revises and updates the schedule through the course of the program.
• Hands-on work habit and down-to-earth personality with ability to solve problems and mitigate issues.
• Solid knowledge of Good Clinical Practices, Regulations and Guidance, including Clinical Laboratory Standards relative to the conduct of clinical trials and evidence generation for in-vitro products.
• Ability to manage clinical strategy plan, clinical project schedule, generate timelines, and clinical project deliverables under supervision.
• Facilitates availability of required supplies and/or resources for individual and/or group activities.
• Carries out tasks and activities that are defined in local business/operating plans.
• Strong training and presentation skills and intermediate project management knowledge

Education and Experience

• Advanced Degree, Master's or MD or PhD or other allied health or other allied health degree/certification in a health-related or life science Required
• A minimum 2 years of experience in a regulated industry environment, such as in vitro device, medical device, biotech, or pharmaceutical industries.

Assets

• Individuals with previous direct clinical trials experience within an IVD and/or medical device industry are highly desired.
• Individuals with experience managing medium to large size clinical studies budgets are highly desired, preferentially in Hematology, Immunology or Oncology.
• Individuals with previous flow cytometry experience or clinical laboratory experience are desirable.