H-1B Visa Study Start Up Jobs
Study Start Up roles sit at the intersection of clinical research coordination and regulatory compliance, two areas where H-1B visa specialty occupation requirements are consistently met. Employers in this space regularly file LCAs and sponsor H-1B transfers, making it a viable target for skilled professionals seeking long-term U.S. work authorization.
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Get Access To All JobsINTRODUCTION
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.
ROLE AND RESPONSIBILITIES
The Head of Global Strategic Feasibility and Study Start-Up at BeOne is a senior leadership role responsible for overseeing the strategic planning and feasibility assessments for global clinical studies. This individual leads the global strategic feasibility team, works with regional strategic feasibility teams, and collaborates closely with cross-functional stakeholders while leading a team of Study Start Up documentation specialists to accelerate key study level/asset documentation while driving quality and consistency. This individual is accountable to ensure global and country level strategic feasibility during the study planning stage to support the study execution with high quality study start-up documentation and predictable enrollment forecasts based upon key data analytics and company performance curves. The Head of Global Strategic Feasibility and Study Start-Up plays a crucial role in shaping the company's global clinical study strategy and decision-making process while directly impacting study-start up timelines. This individual is accountable to establish and improve the global strategic feasibility processes, procedures, and systems and study start-up documentation to strive for continuous optimization.
Essential Functions of the Job:
- Strategic Planning: overseeing the global strategic feasibility proposals for global clinical studies in alignment with corporate objectives, therapeutic areas, and regional requirements.
- Ensures standardization in data documentation, data assets, tools and processes globally to advise quality decision making at TA, indication, program and study levels.
- Continuous Improvement: Drive process optimization initiatives to enhance feasibility assessment methodologies, tools, and metrics, ensuring efficiency, quality, and scalability.
- Stakeholder Collaboration: Collaborate with internal stakeholders, including Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, and Biostatistics etc. to ensure alignment and provide strategic input for study design and execution.
- External Partnerships: Establish and maintain effective partnerships with external organizations, including vendors, investigative sites, and key opinion leaders, to enhance study feasibility and optimize resources.
- Team Leadership: Build, lead, and mentor a high-performing team of feasibility and study start-up professionals, fostering a collaborative and innovative work environment.
- Risk Management: Identify potential risks and challenges in study feasibility and develop mitigation strategies to minimize their impact on timelines, budget, and study success.
- Reporting and Communication: Prepare and present feasibility process and tool development progress, metrics, and recommendations to senior management and key stakeholders, fostering transparency and informed decision-making.
- Participates in global projects representing Global Clinical Operations and Global Strategic Feasibility team to support BeOne R&D goals.
- Supervisory Responsibilities: Line management of global strategic feasibility team members. Drives high level of ownership and accountability within team and with external stakeholders.
BASIC QUALIFICATIONS
- Experience with study optimization vendors, tools, and methods.
- Experience managing process and timelines associated with Study Start-Up documentation including Informed Consent development, Lab Manual creation, Investigator Brochures, etc.
- Demonstrated process improvement experience to map processes, measure components and deliver standardization and efficiency.
- Proven experience in data analysis, data interpretation to drive informed decision making.
- Expertise in principles driving country/site identification, feasibility, and study startup strategies.
- Demonstrated experience in managing, influencing, building, and managing relationships and achieving results with senior partners in an environment with competing priorities.
- Clinical Development Expertise: Strong understanding of clinical study operations, feasibility assessment, and global clinical development processes. Knowledge of multiple therapeutic areas is highly desirable.
- Leadership Skills: Proven ability to lead and inspire teams, fostering a collaborative and results-oriented culture. Experience managing cross-functional teams and working in a matrix environment.
- Strategic Thinking: Demonstrated ability to think strategically and make informed decisions based on comprehensive feasibility assessments and business objectives.
Computer Skills: Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Studytrove, etc.) and additional feasibility software.
OTHER QUALIFICATIONS
Travel: As needed
EDUCATION REQUIRED
Bachelor’s degree or higher in a scientific, medical or healthcare discipline; An advanced degree (e.g., MSc, PhD, MBA) is preferred. BA or BS with 12+ years of experience in Feasibility, Clinical Study Management, Personnel Management and Operations Management or an MA/MS with 8+ years of experience. Prior experience in a leadership capacity is essential.
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
COMPENSATION
- Salary Range: $206,200.00 - $276,200.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
INTRODUCTION
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.
ROLE AND RESPONSIBILITIES
The Head of Global Strategic Feasibility and Study Start-Up at BeOne is a senior leadership role responsible for overseeing the strategic planning and feasibility assessments for global clinical studies. This individual leads the global strategic feasibility team, works with regional strategic feasibility teams, and collaborates closely with cross-functional stakeholders while leading a team of Study Start Up documentation specialists to accelerate key study level/asset documentation while driving quality and consistency. This individual is accountable to ensure global and country level strategic feasibility during the study planning stage to support the study execution with high quality study start-up documentation and predictable enrollment forecasts based upon key data analytics and company performance curves. The Head of Global Strategic Feasibility and Study Start-Up plays a crucial role in shaping the company's global clinical study strategy and decision-making process while directly impacting study-start up timelines. This individual is accountable to establish and improve the global strategic feasibility processes, procedures, and systems and study start-up documentation to strive for continuous optimization.
Essential Functions of the Job:
- Strategic Planning: overseeing the global strategic feasibility proposals for global clinical studies in alignment with corporate objectives, therapeutic areas, and regional requirements.
- Ensures standardization in data documentation, data assets, tools and processes globally to advise quality decision making at TA, indication, program and study levels.
- Continuous Improvement: Drive process optimization initiatives to enhance feasibility assessment methodologies, tools, and metrics, ensuring efficiency, quality, and scalability.
- Stakeholder Collaboration: Collaborate with internal stakeholders, including Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, and Biostatistics etc. to ensure alignment and provide strategic input for study design and execution.
- External Partnerships: Establish and maintain effective partnerships with external organizations, including vendors, investigative sites, and key opinion leaders, to enhance study feasibility and optimize resources.
- Team Leadership: Build, lead, and mentor a high-performing team of feasibility and study start-up professionals, fostering a collaborative and innovative work environment.
- Risk Management: Identify potential risks and challenges in study feasibility and develop mitigation strategies to minimize their impact on timelines, budget, and study success.
- Reporting and Communication: Prepare and present feasibility process and tool development progress, metrics, and recommendations to senior management and key stakeholders, fostering transparency and informed decision-making.
- Participates in global projects representing Global Clinical Operations and Global Strategic Feasibility team to support BeOne R&D goals.
- Supervisory Responsibilities: Line management of global strategic feasibility team members. Drives high level of ownership and accountability within team and with external stakeholders.
BASIC QUALIFICATIONS
- Experience with study optimization vendors, tools, and methods.
- Experience managing process and timelines associated with Study Start-Up documentation including Informed Consent development, Lab Manual creation, Investigator Brochures, etc.
- Demonstrated process improvement experience to map processes, measure components and deliver standardization and efficiency.
- Proven experience in data analysis, data interpretation to drive informed decision making.
- Expertise in principles driving country/site identification, feasibility, and study startup strategies.
- Demonstrated experience in managing, influencing, building, and managing relationships and achieving results with senior partners in an environment with competing priorities.
- Clinical Development Expertise: Strong understanding of clinical study operations, feasibility assessment, and global clinical development processes. Knowledge of multiple therapeutic areas is highly desirable.
- Leadership Skills: Proven ability to lead and inspire teams, fostering a collaborative and results-oriented culture. Experience managing cross-functional teams and working in a matrix environment.
- Strategic Thinking: Demonstrated ability to think strategically and make informed decisions based on comprehensive feasibility assessments and business objectives.
Computer Skills: Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Studytrove, etc.) and additional feasibility software.
OTHER QUALIFICATIONS
Travel: As needed
EDUCATION REQUIRED
Bachelor’s degree or higher in a scientific, medical or healthcare discipline; An advanced degree (e.g., MSc, PhD, MBA) is preferred. BA or BS with 12+ years of experience in Feasibility, Clinical Study Management, Personnel Management and Operations Management or an MA/MS with 8+ years of experience. Prior experience in a leadership capacity is essential.
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
COMPENSATION
- Salary Range: $206,200.00 - $276,200.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Study Start Up
Map your degree to SOC codes
Study Start Up work typically maps to Clinical Research Coordinator or Regulatory Affairs Specialist SOC codes. Pull the O*NET profile for each to confirm the listed degree requirements align with your credentials before targeting employers.
Prioritize employers with active LCA filings
Contract research organizations and academic medical centers file LCAs regularly for Study Start Up roles. Use the OFLC Wage Search to confirm an employer has filed in your target occupation and geography before applying.
Search verified H-1B sponsors on Migrate Mate
Migrate Mate filters Study Start Up jobs by employers with confirmed H-1B filing history, so you skip companies that won't sponsor. Narrow by location and role type to build a shortlist before outreach.
Get your credentials evaluated early
If your clinical research or life sciences degree is from outside the U.S., get a credential evaluation completed before interviews. Employers and USCIS both need to confirm your degree meets specialty occupation standards for this role.
Clarify LCA timing during the offer stage
Ask the hiring manager whether the employer files the LCA in-house or through outside counsel. In-house filers often move faster, which matters if you're on OPT cap-gap or need to hit the October 1 H-1B start date.
Understand the 60-day portability window
If you're transferring an existing H-1B to a new Study Start Up employer, your new employer can file a concurrent I-129 so you're authorized to start without waiting for approval. Confirm this option before giving notice at your current role.
H-1B Visa Study Start Up: Frequently Asked Questions
Does a Study Start Up role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. Study Start Up roles require applied knowledge of regulatory submissions, protocol feasibility, and site activation processes that typically demand a bachelor's degree or higher in clinical research, life sciences, or a related field. USCIS evaluates specialty occupation on a case-by-case basis, so your employer's petition needs to document that the specific position requires that degree-level expertise.
Which types of employers commonly sponsor H-1B visas for Study Start Up positions?
Contract research organizations, academic medical centers, hospital networks, and mid-size biotech companies are the most consistent H-1B sponsors for Study Start Up roles. Site management organizations that manage multi-site trials also file regularly. You can find employers with verified H-1B filing history for this role type on Migrate Mate, filtered by location and industry.
Can I transfer my H-1B to a new employer for a Study Start Up role mid-year?
Yes. H-1B portability under AC21 lets you start working for a new employer as soon as the transfer petition is filed with USCIS, without waiting for approval, as long as your current H-1B was approved and you've been in valid status. Your new employer files an I-129 with a certified LCA covering your Study Start Up title and work location.
What documentation strengthens an H-1B petition for a Study Start Up role?
The petition needs an LCA certified by DOL at the correct prevailing wage level, a detailed job description tying the role to specialty occupation criteria, and evidence that the position requires a specific degree field. Clinical research certifications, protocol experience letters from previous employers, and IRB or regulatory training records all help establish that the role isn't a generalist position.
How does the H-1B cap lottery affect Study Start Up job seekers?
Most Study Start Up roles at for-profit employers are subject to the annual H-1B cap, which means your petition enters the lottery held each spring for an October 1 start date. Roles at nonprofit research institutions or universities may qualify for cap-exempt status, letting employers file year-round. USCIS publishes cap-exempt employer categories, and confirming your target employer's status before accepting an offer saves significant planning effort.