Associate Director, Investigator Initiated Trials
BeiGene
Toronto, Ontario, Canada
Contract
Competitive
OfficeDirector
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Associate Director, IIT Operations will play a supportive leadership role within the BeOne IIT Team, providing strategic and operational oversight across the global Investigator‑Initiated Trials (IIT) program. This role is responsible for centralized project management of all IIT projects and initiatives, serving as a floating Study Manager across regions as needed, and leading research‑focused collaborations with external investigators and academic partners.
This individual will work cross‑functionally with Medical Affairs, Clinical Development, Regulatory, Legal, Compliance, Contracts, and other key partners to ensure high‑quality, compliant, and timely execution of the IIT portfolio. The Associate Director will also support process optimization, KPI tracking, and program‑level governance efforts.
Location: Canada
Essential Functions of the Job:
IIT Study Management (~60%)
Serve as a flexible Study Manager for IITs across NAMA, JAPAC, EU and New Market regions
Oversee operational execution of the entire lifecycle IIT studies, including feasibility, operational review, contracting, study start‑up, drug supply coordination, monitoring progress, and study closeout.
Responsible for ensuring the grant management system is always up-to-date with current information from the sponsor-investigator and assess impact on changes in assumption (e.g., changes to enrollment projections, timeline and downstream effects on payment milestones).
Close collaboration with regional IIT leads, field team, medical leads and leadership to address underperforming studies and strategize on a risk mitigation plan. Study managers are expected to assess for early warning signs of enrollment and timeline deviation and escalate ASAP.
Close collaboration with IIT budget forecast tracker lead and Finance in managing study budgets and milestone payments.
Ensure all activities are conducted in compliance with BeOne policies, SOPs, GCP, and regional regulations.
Act as the primary operational contact for investigators, research sites, partners, and internal stakeholders.
Oversee IIT agreement negotiations to ensure efficient processing and escalation of potential issues.
IIT Research Collaborations (~20%)
Project management of solicited and unsolicited research partnerships and scientific collaborations with academic institutions, cooperative groups, and key research networks.
Support development of collaboration frameworks, data‑sharing agreements, and joint project plans.
Facilitate scientific and operational discussions to advance external research aligned with the Medical/Scientific strategy.
Ensure collaboration milestones, deliverables, and expectations are met.
Project Management of IIT Initiatives (~15%)
Lead end‑to‑end project management of all IIT team initiatives, including process improvements, system enhancements, governance updates, and portfolio‑level activities.
Develop project plans, timelines, risk logs, communication plans, and resource assessments for all IIT projects.
Drive cross-functional collaboration and ensure alignment with internal stakeholders across Medical Affairs, Clinical Development, Legal, Compliance, and Finance.
Monitor progress and proactively address risks, bottlenecks, and dependencies that may impact team goals.
Support development and presentation of project dashboards, metrics, and reports for senior leadership and governance committees.
Contribute to development and refinement of IIT processes, SOPs, work instructions and checklist documents.
Support implementation and optimization of IIT systems/platforms (e.g., submission portals, tracking systems).
Identify opportunities to drive operational excellence, standardization, and efficiency across the IIT program.
MIRC Governance Support & Back-up Coverage (~5%)
Support Medical Internal Review Committee (MIRC) Lead in operational review of proposals and protocols. Responsibilities include scheduling, agenda and slide preparation, adjudicating comments, creating meeting minutes and following up on action items.
To ensure business continuity, this role will perform as the primary back-up to the MIRC for short-term coverage.
Required Education:
BA/BS Degree is required, Advanced degree (MD/PharmD, MS) is preferred.
Required Qualifications:
MD/PharmD with 4 + years of experience within the pharmaceutical industry, clinical research, consulting and/or CRO.
Masters Degree with 6 + years of experience within the pharmaceutical industry, clinical research, consulting and/or CRO.
Bachelors Degree with 8 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO.
5+ years of experience in clinical research, project management, Medical Affairs operations, or IIT management(Preferred).
Prior operational experience managing preclinical and clinical IITs (IST, ISR, external research collaborations).
Demonstrated experience managing clinical research projects or programs in a pharma, biotech, or academic research setting.
Strong understanding of GCP, clinical research regulations, and IIT operational workflows.
Excellent project management, prioritization, organizational skills, decision-making, and time management skills in a fast-paced environment.
Exceptional communication and interpersonal skills with the ability to influence without authority.
Proven ability to work independently in a fast‑paced, matrixed environment.
Prior experience in IIT governance committee, PMP/or equivalent, people management, a plus.
Supervisory Responsibilities:
No direct reports
Role may provide mentorship to junior colleagues
Role may provide short-term leadership coverage to the IIT lead to ensure business continuity
Computer Skills:
Microsoft Office Suite
Power BI dashboard
Smartsheet
Grants management submission portal software
Clinical Trial Management Software (CTMS) or other study management software
Familiarity with other industry applications such as: Veeva, Agiloft and SAP Ariba
Role Specific Competencies
Strategic thinking and problem-solving
Cross-functional leadership
Relationship and stakeholder management
Operational excellence and execution focus
Adaptability and resourcefulness
Scientific/clinical literacy
Strong ethical judgment and compliance‑mindset
Travel:
Work related travel approximately 5-10%.
Please note that this job posting is being advertised to fill a budgeted position.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.