Manages relationships with internal and external stakeholders.
Supports logistics and drives timelines and communication to ensure successful execution of IND-enabling packages and nonclinical portfolios for our Sponsors.
Oversees nonclinical study packages or portfolios from award to completion.
Plans and facilitates internal and external kick off meetings and ongoing team meetings.
Uses interpersonal skills to liaise between teams to ensure requirements, scope and milestones are understood and met.
Serves as an advocate for the Sponsor and communicates Sponsor expectations.
Contributes to contingency planning for key resources and activities.
Develops and maintains appropriate tools to provide regular updates to stakeholders.
Works closely with Business Development and senior members of the Program Management team.
Requirements
Master’s degree or equivalent in Biotechnology, Toxicology, Pharmacology, or a similar Life Sciences field.
Five years as a Study Director or Nonclinical Project Manager (or similar client facing role) in a pharmaceutical, biotechnology or contract research organization setting.
Ability to demonstrate an understanding of early-stage drug development, leading to IND submissions.
Experience leading drug development programs would be beneficial.
Excellent verbal and written communication skills.
Professional attitude and strong interpersonal skills.
Ability to work well with a multi-disciplinary team of professionals.
Client-focused approach.
Solution-focus and ability to creatively solve problems and resolve issues.
Ability to take initiative and use sound judgement.
Ability to acquire and apply knowledge quickly.
Flexible attitude with an ability to effectively prioritize.
Understanding of early-stage drug development process and applicable regulatory guidelines.
Knowledge of regulatory guidelines for preclinical and clinical studies as well as GCP and GLP procedures.
Ability to travel for Sponsor visits, site visits and/or meetings (approx. 20%).
Software: MS Office, Client Relationship Management Systems, Timeline Management Software (Smartsheet, MS Project)
Benefits
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Telework when applicable.
Training & Development Programs
Employee Referral Bonus Program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
BiotechnologyToxicologyPharmacologyearly-stage drug developmentIND submissionsdrug development programsregulatory guidelinesGCP proceduresGLP procedures