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Associate Director, Clinical Site Contracts

4 months ago

Sydney, Australia BeiGene Full time

Job Description:

About the Company:

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 10,000 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.

BeiGene 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.

Role and Responsibilities:

Responsible for management of all global 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. Provides the supervision, direction, and performance metrics for the Clinical Contracts team. Responsible for ensuring that the negotiation process is maintained and improved to meet the financial and operational needs of the BeiGene. Strong knowledge of Study Start-up and able to provide support and supervision 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 an escalation point for Clinical Site Contracts and provide global oversight at the Program level. Leverage leading industry tools and data sources to provide budget and contract feedback aligned with BeiGene parameters and fair market value guidance. Recognize and improve potential delays providing solutions to resolve and escalate non-performance. 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. Ensures final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal and regulatory requirements. Perform Global level oversight of Site Contract Associates to ensure contracts in the region are completed per company standards/timelines. Implement mitigation plans as necessary in the assigned region. Provides the supervision, direction, and performance metrics for the Clinical Contracts team. Serve as a point of escalation for sites that are unresponsive or slow to negotiate. Development and implementation of new policies and procedures based on identified needs Create and develop effective contract templates and tools Other tasks and responsibilities as requested by departmental and company leadership.

Supervisory Responsibilities:  

Supervise and provide direction to Contract Associates/Analysts or Contract Managers in APAC.

Qualification Required:

Computer Skills:

Microsoft Office desktop applications, CTMS, Contract Lifecycle Management System, Veeva, Jira, Beep/SharePoint

Qualifications:

Excels in contract and budget creation and negotiations: Demonstrated proficiency in the development and negotiation of contracts and budgets to achieve mutually beneficial results for internal and external parties Experience leading and facilitating team members and peers: Demonstrated leadership skills; successfully managed definition, implementation, and ongoing assessment of new processes Practices professionalism and integrity in all actions: Shows support for teamwork, cooperation, self-control, and flexibility to get work done regardless of efforts required Able to work under pressure: Demonstrates an understanding of deadlines by meeting Company needs promptly, meeting committed timelines and assisting others in doing the same Has successfully developed and administered process training and successfully supported others outside direct responsibility Must be a multi-tasker acclimated to a challenging, fast-paced environment, implementing strategic approaches while generating data-driven sustainable value and savings deep 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 efficiently and effectively with all levels of an organization. Full working rights in Australia (PR or Citizen)

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 and performance-based annual equity plan)

Full-time working from home

In-house and external learning and development opportunities

Fantastic benefits program as per the current policy including:

Personal health insurance reimbursement

Home-office setup allowance

Monthly reimbursement for home office expenses (i.e. internet, mobile..)

Group life insurance & income protection insurance

Wellness benefits (Employee Assistance Program)

Active social club

And more as the benefit programs keep improving

Plus you get to work with a dynamic team of collaborative, supportive, diverse and fun professionals whose mission is clear: Cancer has no borders and neither do we.

BeiGene is proud to be an Equal Opportunity Employer: