E-3 Visa Clinical Operations Director Jobs
Clinical Operations Director roles in the U.S. require a bachelor's degree in a clinical or life sciences field, making them a strong fit for E-3 visa sponsorship. The E-3 has no lottery, no annual cap pressure, and renews in two-year increments, so your career progression doesn't depend on a single filing window.
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Get Access To All JobsAssociate Director, Clinical Operations
Skills & Attributes
- Excellent organizational and leadership skills with very strong experience in executing Phase 1-3 global clinical trials.
- Experience leading a team managing international trials using CROs from set-up through to close out.
- Global clinical research expertise with excellent line and matrix management skills.
- Excellent teamwork, communication and interpersonal skills with a demonstrated ability to effectively develop talent.
- Highly developed critical thinking, prioritization and risk management skills to drive successful execution of trials.
- Strong knowledge of GCP and related international regulations.
- Excellent written and spoken English.
- Ability to work in a fast-paced dynamic environment.
Experience Required
- 5+ years global experience, with 5+ years at Senior Manager level or above in a Biotech/Pharma/CRO.
- Proven track record of effective leadership in a multi-disciplinary team.
Education Required
- Bachelor’s Degree
Travel Required
- Yes (up to 15%)
Job Summary
The Associate Director is accountable for the day-to-day management of the assigned clinical operations team. Provide strategic direction and leadership for the execution of trials. Accountable to ensure the delivery of appropriately skilled resources so that trials are delivered according to corporate objectives. Responsible for the delivery of clinical study milestones. Provide hands-on operations as necessary. Overseeing vendor activities with appropriate risk mitigations and contingency planning. Contribute strategic clinical operations input to the clinical development of Protagonist assets.
Core Responsibilities and skills
- Primary operational leader of the clinical program implementation.
- Participate in resource allocation, prioritization and budgeting to ensure department goals and milestones are aligned and tracking to corporate objectives. Line management responsibilities include hiring talent, performance development and mentorship.
- Ensure ongoing strong vendor interactions and collaborations, including hands-on interactions and management.
- Develop and manage integrated study timelines and leads study strategy meetings to review trial status/progress.
- Provide input on strategy in the development of realistic project milestones and deliverables. Apply appropriate project management tools and processes.
- Lead ongoing risk assessments with accompanying mitigation plans and contingency plans. Strong abilities to problem-solve and diagnose the root causes and implement the appropriate corrective actions.
- Provide input to the development and review of study and overall clinical program budgets. Take corrective measures as necessary to keep project(s) in line within agreed timelines, quality, budget and performance metrics. Assess the impact of project scope changes to understand the implications on agreed plans and budgets.
- Help develop site recruitment, enrollment and engagement strategies. Present overall scorecard and analysis to senior management.
- Manage interdisciplinary activities to ensure clinical operations team collaborates effectively to set achievable goals, milestones and timelines. Establish strong cross-functional relationships and manage cross functional resources and study deliverables.
- Identify and implement best practices and leverage lessons learnt and process improvements. Collaborate with Clinical Quality Assurance to develop a strategic plan for CRO and vendor audits. Proactively seek out, recommend and execute process improvements.
- Excellent oral and written communication skills with the ability to communicate clearly, succinctly and credibly to all organizational levels. A proven ability to anticipate and respond quickly to key emerging information.
- Maintain oversight and contribute to the development of the department’s standard operating procedures (SOPs). Ensure plans are developed in accordance with SOPs, and there is compliance with all controlled document requirements and other requirements to help guarantee quality deliverables.
- Maintain knowledge of product areas, current trends, and literature to help ensure compliance.
- Drive excellence in the overall clinical operational activities across multiple clinical trials. Creative, dynamic and results-oriented. Act with integrity and respect at all times.
- Proficient in the use of computer and software systems (e.g., Excel, MS Project).
- Perform other duties, initiatives and assignments as requested for the overall performance of the function and the company.
The base pay range for this position at commencement of employment is expected to be between $185K and $205K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc., a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.
Associate Director, Clinical Operations
Skills & Attributes
- Excellent organizational and leadership skills with very strong experience in executing Phase 1-3 global clinical trials.
- Experience leading a team managing international trials using CROs from set-up through to close out.
- Global clinical research expertise with excellent line and matrix management skills.
- Excellent teamwork, communication and interpersonal skills with a demonstrated ability to effectively develop talent.
- Highly developed critical thinking, prioritization and risk management skills to drive successful execution of trials.
- Strong knowledge of GCP and related international regulations.
- Excellent written and spoken English.
- Ability to work in a fast-paced dynamic environment.
Experience Required
- 5+ years global experience, with 5+ years at Senior Manager level or above in a Biotech/Pharma/CRO.
- Proven track record of effective leadership in a multi-disciplinary team.
Education Required
- Bachelor’s Degree
Travel Required
- Yes (up to 15%)
Job Summary
The Associate Director is accountable for the day-to-day management of the assigned clinical operations team. Provide strategic direction and leadership for the execution of trials. Accountable to ensure the delivery of appropriately skilled resources so that trials are delivered according to corporate objectives. Responsible for the delivery of clinical study milestones. Provide hands-on operations as necessary. Overseeing vendor activities with appropriate risk mitigations and contingency planning. Contribute strategic clinical operations input to the clinical development of Protagonist assets.
Core Responsibilities and skills
- Primary operational leader of the clinical program implementation.
- Participate in resource allocation, prioritization and budgeting to ensure department goals and milestones are aligned and tracking to corporate objectives. Line management responsibilities include hiring talent, performance development and mentorship.
- Ensure ongoing strong vendor interactions and collaborations, including hands-on interactions and management.
- Develop and manage integrated study timelines and leads study strategy meetings to review trial status/progress.
- Provide input on strategy in the development of realistic project milestones and deliverables. Apply appropriate project management tools and processes.
- Lead ongoing risk assessments with accompanying mitigation plans and contingency plans. Strong abilities to problem-solve and diagnose the root causes and implement the appropriate corrective actions.
- Provide input to the development and review of study and overall clinical program budgets. Take corrective measures as necessary to keep project(s) in line within agreed timelines, quality, budget and performance metrics. Assess the impact of project scope changes to understand the implications on agreed plans and budgets.
- Help develop site recruitment, enrollment and engagement strategies. Present overall scorecard and analysis to senior management.
- Manage interdisciplinary activities to ensure clinical operations team collaborates effectively to set achievable goals, milestones and timelines. Establish strong cross-functional relationships and manage cross functional resources and study deliverables.
- Identify and implement best practices and leverage lessons learnt and process improvements. Collaborate with Clinical Quality Assurance to develop a strategic plan for CRO and vendor audits. Proactively seek out, recommend and execute process improvements.
- Excellent oral and written communication skills with the ability to communicate clearly, succinctly and credibly to all organizational levels. A proven ability to anticipate and respond quickly to key emerging information.
- Maintain oversight and contribute to the development of the department’s standard operating procedures (SOPs). Ensure plans are developed in accordance with SOPs, and there is compliance with all controlled document requirements and other requirements to help guarantee quality deliverables.
- Maintain knowledge of product areas, current trends, and literature to help ensure compliance.
- Drive excellence in the overall clinical operational activities across multiple clinical trials. Creative, dynamic and results-oriented. Act with integrity and respect at all times.
- Proficient in the use of computer and software systems (e.g., Excel, MS Project).
- Perform other duties, initiatives and assignments as requested for the overall performance of the function and the company.
The base pay range for this position at commencement of employment is expected to be between $185K and $205K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc., a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.
See all E-3 Visa Clinical Operations Director Jobs
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Get Access To All JobsTips for Finding E-3 Visa Sponsorship in Clinical Operations Director
Align your credentials to specialty occupation standards
E-3 visa eligibility requires your degree to directly relate to clinical operations, not just adjacent fields. A Bachelor of Health Sciences or Nursing carries more weight than a general management degree when a consular officer reviews your application.
Target employers with active clinical trial infrastructure
Contract research organizations, biotech firms, and academic medical centers file LCAs regularly for director-level clinical roles. Searching DOL's Foreign Labor Application Gateway by job title filters employers with documented E-3 or H-1B visa filing history in this occupation.
Raise E-3 early in offer negotiations
Many U.S. clinical employers are unfamiliar with the E-3 and assume Australian hires require H-1B. Clarifying upfront that E-3 has no lottery and that employer costs are lower often removes the hesitation that kills sponsorship conversations before they start.
Confirm the LCA wage tier matches your seniority
DOL sets four prevailing wage levels for each occupation. Director-level roles typically fall at Level III or IV. If your offer letter lists a Level II wage, the LCA certification may be challenged, delaying your entire application.
Use Migrate Mate's E-3 filing service for end-to-end preparation
Once you have an offer, use Migrate Mate's E-3 filing service to handle your LCA filing, DS-160, and consulate preparation. Clinical Operations Director applications often involve complex job duty descriptions that need to clearly satisfy specialty occupation criteria.
Prepare a precise specialty occupation letter before your interview
Your employer's support letter must demonstrate that the Clinical Operations Director role routinely requires a specific bachelor's degree, not just that a degree is preferred. Consular officers at Sydney and Melbourne increasingly scrutinize director-level roles where management duties could appear non-specialty.
E-3 Visa Clinical Operations Director: Frequently Asked Questions
How do I find Clinical Operations Director jobs with E-3 visa sponsorship?
Migrate Mate is the most direct way to search for Clinical Operations Director roles where employers have active E-3 or H-1B sponsorship history. Standard job boards don't filter by visa sponsorship intent, which means most results require manual follow-up. Migrate Mate surfaces roles at employers with documented sponsorship activity, saving you the back-and-forth of asking each recruiter separately.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does a Clinical Operations Director role qualify as a specialty occupation for E-3 purposes?
Yes, provided the position normally requires a bachelor's degree or higher in a specific field such as clinical research, nursing, health sciences, or life sciences. The key word is 'normally.' If the employer's own job postings or internal grading accept any degree field, a consular officer may question specialty occupation status. Your employer's support letter should cite the specific educational requirement tied to the role's clinical functions.
How does the E-3 compare to the H-1B for a Clinical Operations Director?
The E-3 has no annual cap and no lottery, so there's no risk of being selected out before you can start. The H-1B runs an oversubscribed lottery each April, meaning even a qualifying director-level candidate may wait years for a slot. E-3 also allows you to apply directly at a U.S. consulate in Australia without waiting for USCIS petition approval, which shortens the timeline to starting work significantly.
Can I transfer my E-3 if I move to a different clinical employer mid-career?
Yes, but the process restarts with the new employer. Your new employer must file a fresh LCA with DOL and issue a new support letter confirming the role meets specialty occupation and prevailing wage requirements. You'll need a new visa stamp if your current stamp has expired, which means returning to Australia for a consulate interview. If your stamp is still valid, some attorneys argue a portability argument, but consular practice varies.