Regional Contracts Lead, Clinical Site Contracts

BeOne Medicines Ltd.; Sydney; On-site; AUD 150,000 - 190,000; Full time

Benefits offered by this job

Bonus scheme

Company shares

Learning & development opportunities

Benefits program

Job summary

BeOne Medicines is seeking a Contract Lifecycle Manager to oversee regional clinical contract agreements, including CTAs, investigator, and site contracts. You will lead the regional contracts team, ensuring timely execution and adherence to BeOne’s standards and budgets.

You will negotiate budgets within FMV, partner with Clinical Operations, and drive process improvements across portfolios while maintaining compliance with ICH-GCP and regulatory requirements.

Qualifications

• Experience in clinical trial contracting and budgets.
• Knowledge of ICH-GCP and pharmaceutical regulations.
• Ability to negotiate and manage complex agreements.
• Strong planning, organization and communication skills.

Responsibilities

• Oversee regional clinical contract agreements lifecycle.
• Lead regional Contract Managers and Associates.
• Negotiate site budgets within FMV and internal approvals.
• Collaborate with Clinical Operations and CBO colleagues to improve metrics.
• Develop and implement policy changes for contracts and budgets.

Skills

Negotiation

Leadership

Project management

English fluency

Education

Bachelor’s degree; JD highly preferred

Tools

CTMS

Contract Lifecycle Management System

Veeva

Jira

Sharepoint

Job description

About Us

and follow us on LinkedIn and X (formerly known as Twitter).

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.

About Us

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 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

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.

Job Description

General Description:

The Contract Lifecycle Manager is responsible for oversight and on time execution of all regional clinical contract agreements including, but not limited to, Clinical Trial Agreements (CTAs), investigator agreements, confidentiality agreements, ancillary agreements, pharmacy agreements, site master service agreements, consulting agreements, single-service, subcontractor agreements among other agreements in the clinical contract space.

Essential Functions Of The Job

• Functional line management of the regional based Clinical Contracts team including Contract Managers and Contract Associates or equivalent and delivers individual and group feedback to support ongoing development.
• The Regional Site Contracts Lead may have authority through a POA to sign Investigator Contracts as authorized by BeOne Medicines Legal and Tax
• Responsible for ensuring that the negotiation process is maintained and improved to meet the financial and operational needs of the BeOne Medicines.
• Responsible for ensuring the negotiation of Clinical Site budgets is within Fair Market value and internal approval guidelines.
• Partner with Clinical Operations teams, and CBO colleagues to improve overall Clinical Site Contract and budget metrics and implement processes.
• Ensure standards are applied to the Clinical Site Contract and budget processes across project portfolios and support continuous improvement activities while developing TA-aligned strategies.
• Serve as a regional escalation point for Clinical Site Contracts and provide regional oversight at the Program level.
• Leverage leading industry tools and data sources to provide budget and contract feedback aligned with BeOne Medicines parameters and fair market value guidance.
• Recognize and improve potential delays providing solutions to resolve and elevate nonperformance.
• Provide oversight and guidance for clinical site contract negotiations, identify any potential risks, and be accountable for the overall contracting timelines/lifecycle in various regions.
• Perform Regional level oversight of Clinical Site Contracts to ensure contracts in the region are completed per company standards/timelines. Implement mitigation plans as necessary in the assigned region.
• Development and implementation of new policies and procedures based on identified needs
• Other tasks and responsibilities as requested by departmental and company leadership.

Supervisory Responsibilities

• Yes

Computer Skills

• Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Sharepoint etc.

Qualification Required

Education Required:

• Bachelor’s degree; JD highly preferred or 8+ years of outstanding experience managing and negotiating clinical trial agreements and budgets
• Experience in the CRO or pharmaceutical industry is essential.

Other Qualifications

• Good knowledge of ICH-GCP, pharmaceutical related regulations and laws;
• Good understanding of clinical trial contracting process, and relevant clinical operation practices;
• Awareness and understanding of compliance and regulatory matters in clinical research
• Proven negotiation, interpersonal and business skills
• Strong planning and organizational skills and the ability to work independently and effectively in a dynamic environment with competing priorities
• Sense of urgency and strong goal orientation; track-record of meeting deadlines and goals
• Strong written and verbal communication including written and verbal fluency in English and local language (if not English) and interpersonal skills, including conflict resolution and problem solving.
• Proactive and positive team player. Able to maintain high performance during times of ambiguity and change in the work environment.
• Experience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable
• Has knowledge of Intellectual Property issues, Publication issues, Indemnification issues and other standard issues of site contracts within the clinical research area.
• Must be willing to work in a fast-paced environment with time-sensitive material.
• Demonstrated ability to work effectively at all levels of an organization.

Travel: Yes, 10%

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

BeOne Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations. Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to https://beonemedicines.com/privacy-policy. If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you have any concern, please DO NOT provide any resume or other personal information to us.