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About the Role

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, 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.

Responsibilities

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.
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.
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.
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.
Support Medical Internal Review Committee (MIRC) Lead in operational review of proposals and protocols.
Perform as the primary back-up to the MIRC for short-term coverage.

Requirements

BA/BS Degree is required, Advanced degree (MD/PharmD, MS) is preferred.
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 trial 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.
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

Skills

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

Location

Canada

Work Type

Full-time
Hybrid

Experience Level

Associate Director
4+ years
6+ years
8+ years
5+ years

Education Level

BA/BS Degree
Advanced degree (MD/PharmD, MS)

About the Company

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.
We are committed to radically improving access to medicines for far more patients who need them.
Our growing global team of more than 11,000 colleagues spans six continents.
To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
For more information, please visit the link to explore job opportunities in China Mainland.
China Mainland Job Posting
At BeOne, how we work is just as important as the work we do.
Below are our Values that determine the decisions we make and how we do things.
Patients First
Driving Excellence
Bold Ingenuity
Collaborative Spirit

Equal Opportunity

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.