Associate Director, Investigator Initiated Trials

• 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.

• 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%.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.