Associate Director, Regional Clinical Study Management

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.

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement: Fluent English is Required

Preferred Experience: Pharmaceutical/Biotech Industry

Location: Sao Paulo Hybrid

General Description:

The Associate Director Clinical Study Manager (ADCSM) is responsible for the planning, implementation and conduct of large, global, complex oncology clinical trials in Phase I-IV; or multiple smaller early-phase studies. The ADCSM provides leadership within the department/country or region as applicable and makes recommendations with regards to the operational aspects of executing clinical development deliverables.   

Essential Functions:

Clinical Trial Management

• Support the development of the Startup and trial monitoring team in Brazil, including the hiring, training, development and resource allocation of BeiGene staff and oversight of FSP staff in Brazil.
• Demonstrates a high level of clinical operations knowledge, organizational skills, project management and leadership competencies. 
• Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision. 
• Manage CROs, vendors and consultants that are involved with the clinical trial and program.
• Serve as the clinical operations point person managing protocol execution.
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
• Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs as assigned.
• Assist with training and mentoring of internal BeiGene clinical operations staff.
• Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
• Assist in preparation of clinical documentation for IND submissions/updates as well as NDA submission and other regulatory submissions as appropriate.
• Oversees the review and approval of clinical monitoring visit reports and ensures that all outstanding follow-up items are closed out in a timely manner.
• Review and provide input for reports and clinical documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates.
• Manage escalation of study related issues and establish appropriate course of action with Senior Management.
• Liaises with the clinical supply chain lead to ensure forecasting of clinical and non-clinical supplies accurately reflects protocol/trial needs.
• Ensure that the Clinical Trial Master File (TMF) is set up and maintained appropriately throughout the trial. 
• Conduct periodic reviews of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed.
• Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
• Ensures quality clinical data review and data integrity for assigned clinical trial(s)
• Leading, overseeing and participation in governance committees (eg: CST, DCT, JOC)

Fiscal and Contracts Management

• In conjunction with legal group and/or CRO facilitate the development of clinical trial agreements and other relevant documents.
• Review and approve site budgets, manage clinical trial budgets, liaise with finance when financial reporting and projections are requested from management.
• Liaise with Strategic Clinical outsourcing and participate in CRO bid defense meetings and vendor selection activities to include: creation of scope of work, budgets, vendor performance and issue resolution.
• Reconcile and report vendor and site payments, and change orders ensuring accuracy and timely delivery to finance.
• Responsible for creating program-level budget(s).

Cross Functional Mentoring and Leadership

• Work cross-functionally to ensure clinical program timelines and goals are met.
• Provide study-specific mentoring and line management for junior team members, as appropriate.
• Assume leadership role in operational improvement initiatives (e.g.  SOP development, training etc.)

Minimum Requirements – Education and Experience:

• Bachelor’s degree or higher in a scientific or healthcare discipline is requires
• Masters degree preferred
• 10+ years’ experience in clinical research with at least 5 years’ experience in Project Management or Clinical Monitoring preferred. Prior experience participating in a Regulatory Authority inspection strongly preferred.

Other Experience:

• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
• Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
• Proficient written and verbal communication skills.
• Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
• Management experience of CROs, Vendors and Consultants preferred.
• Therapeutic or medical knowledge preferred
• Regulatory authority inspection experience a plus 

Supervisory Responsibilities:

• Line Management of Direct and/or indirect line reports as applicable 
• Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements
• Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans
• Conduct quarterly check-ins and year end performance appraisals for direct reports which includes providing ongoing and constructive feedback

Travel: up to 10-25%

Computer Skills:  Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

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Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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

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.