Job Details

SCOPE:
Responsible for oversight of Investigator Initiated Studies (IIS), Collaborative Research and Expanded Access Programs.

KEY RESPONSIBILITIES:
* Provides operational oversight of the Investigator-Initiated Studies (IIS), Collaborative Research, and Expanded Access Program (EAP) portfolio, including study planning, execution, monitoring, and closeout.
* Leads cross-functional collaboration with Medical Affairs, Clinical Operations, Research & Development, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, Clinical Business Operations, and other relevant functions to support successful study execution.
* Serves as a key operational point of contact for investigators and external research partners and
establishes collaborative and productive relationships with internal stakeholders, the parent company, and relevant affiliates.
* Monitors study progress, including milestones, patient enrollment, timelines, study drug accountability, contractual obligations, and deliverables.
* Identifies and anticipates potential study risks and operational issues, develops mitigation and contingency plans with minimal oversight, and escalates significant issues or cross-functional misalignment to management as appropriate.
* Drives cross-functional alignment on study requirements, timelines, responsibilities, risks, decisions, and next steps.
* Partners with Clinical Supply and cross-functional stakeholders to assess enrollment projections, study drug requirements, supply availability, expiration considerations, and potential supply risks.
* Collaborates with Clinical Business Operations, Finance, Legal, and investigators to negotiate and finalize Clinical Trial Agreements and study budgets, as applicable.
* Monitors study budgets and tracks contractual milestones, deliverables, payments, and other financial obligations, supporting resolution of budget, invoicing, and payment-related issues as needed.
* Prepares and reviews study-related documents and correspondence, as applicable, and ensures required documentation is appropriately maintained and retained.
* Participates in Study Team Meetings, Investigator Meetings, and other study-related meetings, as appropriate.
* Prepares and delivers portfolio and study updates to Medical Affairs, cross-functional stakeholders, and leadership.
* Confirms completion of study deliverables in accordance with contractual requirements.
* Coordinates receipt and internal review of manuscripts, abstracts, presentations, and other scientific deliverables from investigators, including review for applicable legal, intellectual property, and safety considerations.
* Supports CyberGrants Portal submissions and serves as backup to the Administrator.
* Ensures assigned studies adhere to applicable regulations, internal requirements, contractual obligations, and procedures and provides study-specific subject matter expertise and documentation support during regulatory inspections or audits, as applicable.
* Leads or contributes to the development, review, implementation, and continuous improvement of SOPs, processes, tools, templates, and workflows supporting IIS, Collaborative Research, and Expanded Access activities, including training on applicable procedures.
* Maintains knowledge of the oncology therapeutic area, current medical practices, and applicable pharmaceutical regulations to support best practices across activities.
* Serves as a subject matter expert for IIS, Collaborative Research, and Expanded Access operational processes and provides guidance, knowledge sharing, and mentorship to team members and cross-functional stakeholders, as appropriate.
* Performs other duties and responsibilities as requested by senior management.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS:
* Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills.
* Demonstrated skills working within a matrix environment.
* Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors and team members in parent company in Japan.
* Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
* BS./M.S./Ph.D. in a related life science discipline is preferred.
* Thorough understanding of the oncology arena.
* Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
* Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
* Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
* Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
* Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas
* Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
* Strong analytical skills with a data driven approach to planning, executing, and problem solving
* Working knowledge of current global regulatory requirements and guidelines for clinical trials.

Pay ranges between 50-55/hr based on experience