Study Start-Up Head, LATAM

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 required. Spanish is a plus

Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

Location: Sao Paulo Hybrid (2 to 3 days per week in the office)

General Description:

The Study Start-Up Head, LATAM is responsible for the identification, selection, activation, and maintenance of clinical sites of large, global, complex oncology clinical trials in Phase I-IV; or multiple smaller early-phase studies.

The Study Start-Up Head provides leadership within the department/country or region as applicable and makes recommendations with regards to the operational aspects of executing SSU and regulatory clinical development deliverables. The Study Start-Up Head ensures start-up and maintenance clinical trial activities are executed to expected and specified timelines and quality standards, gathers and monitors start-up metrics to measure against KPIs, actively drives best practices and process improvement to effectively achieve SSU goals and proactively seeks opportunities to lead and drive improvements to optimize efficiencies within the Start-Up and regulatory Team as well as the within the Latin America region.

Essential Functions:

• Support the development of the Startup team in Brazil and LATAM, including the hiring, training, development and resource allocation of BeiGene staff and oversight of FSP staff in LATAM region.
• Demonstrates a high level of clinical operations knowledge, organizational skills, project management and leadership competencies. 
• Responsible for the SSU 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, related to SSU activities.
• Establish study SSU 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 supporting the SSU and regulatory strategy developed for LATAM region.
• Assist with training and mentoring of internal BeiGene Clinical Operations staff.
• Demonstrates mastery of skills required to conduct SSU activities from selection through activation and maintenance activities.
• Provide LATAM country-specific SSU expertise to project teams with deep knowledge of country regulations and applicable local requirements.
• Drives clinical trial submissions to country’s regulatory authorities and ethics committees.
• Collaborates with other ClinOps and line functions (e.g., Trial Management, Medical Affairs, New Markets, Regulatory Affairs etc) to support an effective and strategic site selection and build a strong presence of BeiGene in new countries within Americas region
• Support in the development of local workflows to streamline output and deliverables for Clinical Operations in the Americas region.
• Competent in communication and influencing skills to ensure timely follow-up, issue resolution, and report updates
• Manage and maintain SSU resources (i.e., SSU Toolbox (Americas))
• Familiar with ICF GCP, relevant country regulations/guidelines, and SOPs
• Facilitate SSU Forum discussions
• Manage resource allocations and support in resource forecasting activities.
• Contribute to the ongoing improvement of SSU infrastructure in the LATAM and Americas region, as needed.

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 required plus 8+ years’ experience in clinical research with at least 6 years’ experience in Study-Start-up and regulatory in Latin America (preferred)

• Masters degree  in a scientific or healthcare discipline is preferred ; 6+ years’ experience in clinical research with at least 4 years’ experience in Study-Start-up and regulatory in Latin America (preferred).

Other Experience:

• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials 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
• Line management experience
• Functional Service Provider model knowledge and/or experience

Supervisory Responsibilities: 

• Line Management of Direct and/or indirect line reports as applicable
  • Line management – SSU Leads/Managers and Specialists (either internal or FSP), and CTAs (if applicable)
  • Functional management – SSU Leads/Managers and SSU Specialists (FSP)

Onboard new hires; ensure ongoing training compliance.

Conduct regular 1:1s to assess workload, provide guidance and feedback, develop team.

Participate in regular meetings with FSP leadership team.

Meet with FSP line manager(s) to ensure timely feedback.

• 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

#LI-Remote

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.