Clinical Lead Jobs in USA with Visa Sponsorship
Clinical Lead roles in the U.S. are actively sponsored under the H-1B visa, with employers across hospital systems, behavioral health networks, and outpatient clinics regularly filing petitions for qualified candidates. A relevant clinical degree and licensure are typically required. For detailed occupation requirements, see the O*NET profile.
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Company Overview
Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
CRISPR Therapeutics is seeking a Clinical Pharmacology Lead to join us in developing novel gene therapies for serious diseases. This position will report into the Clinical Pharmacology Department, within Clinical Development. The successful candidate will have the opportunity to help answer the questions that shape how our medicines are dosed and developed. This hands-on role spans clinical pharmacology strategy, dose selection, PK/PD analysis, bioanalytical assay strategy, liaising with SMEs for technical development of assays, CRO management, timely data delivery in support of clinical trials, and authoring relevant sections of publication/regulatory submissions. This position requires knowledge of GxP method qualification and GxP-quality level method validation, and associated documentation in support of regulatory submissions. The ideal candidate will demonstrate enthusiasm, passion, attention to detail, and a desire to create important new medicines for patients.
Responsibilities
- Serve as the clinical pharmacology lead on cross-functional program teams, owning clinical pharmacology strategy from IND through later-stage development.
- Drive dose selection and justification by integrating nonclinical, translational, and emerging clinical data. This includes first-in-human dosing, dose escalation, and dose optimization.
- Design PK, PD, and biomarker sampling strategies for clinical protocols in partnership with clinical development, bioanalytical, and clinical operations colleagues.
- Collaborate with clinical operations and clinical sample operations to inform domestic and international sample journey plans and contribute to appropriate clinical laboratory manuals.
- Translate the needs of the clinical program into a portfolio of clinical assays and vendor strategies via collaboration with discovery/pre-clinical scientists, clinical scientists and commercial vendors.
- Select and manage CROs and vendors supporting clinical pharmacology work, including assay development, transfer, validation, and clinical sample analysis, ensuring quality and adherence to timelines.
- Monitor GLP/GCLP quality level method validation of assays at CROs by providing technical expertise and troubleshooting, as needed, and review of documents for multiple clinical projects simultaneously.
- Ensure that assay validation and sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (e.g., FDA, EMA, ICH, WHO, GLP/GCLP, and ISO).
- Work with clinical data management and biometrics to ensure appropriate and timely transfer of data.
- Conduct noncompartmental analyses, population PK/PD modeling, and exposure–response modeling.
- Assess the clinical impact of immunogenicity on PK, PD, safety, and efficacy.
- Interpret clinical pharmacology data and communicate it to program teams and governance bodies as clear, actionable recommendations.
- Author and review clinical pharmacology content for publications, public disclosures, and regulatory documents (e.g., INDs/CTAs, investigator’s brochures, briefing documents, clinical study reports, and BLA/MAA modules), as well as supporting reports and plans such as method development/validation reports, sample analysis reports, and SAPs.
- Manage critical project and program deadlines.
- Stay current on regulatory guidance and the science of cell and gene therapy clinical pharmacology, and contribute to departmental best practices.
Minimum Qualifications
- BS in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, or a related field, with 10+ years of industry clinical pharmacology experience.
- Hands-on proficiency with NCA (e.g., Phoenix WinNonlin) and population modeling approaches (e.g., NONMEM, Monolix, R).
- Working knowledge of bioanalytical techniques, assay development and validation.
- Working knowledge of the principles of clinical trial operations.
- Prior experience working in a biotechnology or pharmaceutical company coordinating and managing external projects at CROs.
- Excellent oral and written communication skills.
- Ability to work independently and collaboratively in a fast-paced, cross-functional, results-oriented team environment.
- Ability to work within tight timelines for successful and timely execution of project and program goals.
- Financial management of projects.
- Ability to travel, if required (Approximately 10%).
Preferred Qualifications
- PhD, PharmD, or equivalent in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, or a related field, with 6+ years of industry clinical pharmacology experience.
- Working knowledge of assay development and validation across molecular (e.g., qPCR, NGS), protein (e.g., ELISA, MSD, Luminex, HPLC), and immunological (e.g., multiparameter flow cytometry, immunohistochemistry) platforms.
- Experience working in gene therapies.
- Experience contributing to a BLA or MAA submission.
- Familiarity with biomarker and immunogenicity strategy.
Competencies
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
Senior Manager: Base pay range of $135,000 to $150,000+ bonus, equity and benefits
The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
Job Description:
Company Overview
Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
CRISPR Therapeutics is seeking a Clinical Pharmacology Lead to join us in developing novel gene therapies for serious diseases. This position will report into the Clinical Pharmacology Department, within Clinical Development. The successful candidate will have the opportunity to help answer the questions that shape how our medicines are dosed and developed. This hands-on role spans clinical pharmacology strategy, dose selection, PK/PD analysis, bioanalytical assay strategy, liaising with SMEs for technical development of assays, CRO management, timely data delivery in support of clinical trials, and authoring relevant sections of publication/regulatory submissions. This position requires knowledge of GxP method qualification and GxP-quality level method validation, and associated documentation in support of regulatory submissions. The ideal candidate will demonstrate enthusiasm, passion, attention to detail, and a desire to create important new medicines for patients.
Responsibilities
- Serve as the clinical pharmacology lead on cross-functional program teams, owning clinical pharmacology strategy from IND through later-stage development.
- Drive dose selection and justification by integrating nonclinical, translational, and emerging clinical data. This includes first-in-human dosing, dose escalation, and dose optimization.
- Design PK, PD, and biomarker sampling strategies for clinical protocols in partnership with clinical development, bioanalytical, and clinical operations colleagues.
- Collaborate with clinical operations and clinical sample operations to inform domestic and international sample journey plans and contribute to appropriate clinical laboratory manuals.
- Translate the needs of the clinical program into a portfolio of clinical assays and vendor strategies via collaboration with discovery/pre-clinical scientists, clinical scientists and commercial vendors.
- Select and manage CROs and vendors supporting clinical pharmacology work, including assay development, transfer, validation, and clinical sample analysis, ensuring quality and adherence to timelines.
- Monitor GLP/GCLP quality level method validation of assays at CROs by providing technical expertise and troubleshooting, as needed, and review of documents for multiple clinical projects simultaneously.
- Ensure that assay validation and sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (e.g., FDA, EMA, ICH, WHO, GLP/GCLP, and ISO).
- Work with clinical data management and biometrics to ensure appropriate and timely transfer of data.
- Conduct noncompartmental analyses, population PK/PD modeling, and exposure–response modeling.
- Assess the clinical impact of immunogenicity on PK, PD, safety, and efficacy.
- Interpret clinical pharmacology data and communicate it to program teams and governance bodies as clear, actionable recommendations.
- Author and review clinical pharmacology content for publications, public disclosures, and regulatory documents (e.g., INDs/CTAs, investigator’s brochures, briefing documents, clinical study reports, and BLA/MAA modules), as well as supporting reports and plans such as method development/validation reports, sample analysis reports, and SAPs.
- Manage critical project and program deadlines.
- Stay current on regulatory guidance and the science of cell and gene therapy clinical pharmacology, and contribute to departmental best practices.
Minimum Qualifications
- BS in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, or a related field, with 10+ years of industry clinical pharmacology experience.
- Hands-on proficiency with NCA (e.g., Phoenix WinNonlin) and population modeling approaches (e.g., NONMEM, Monolix, R).
- Working knowledge of bioanalytical techniques, assay development and validation.
- Working knowledge of the principles of clinical trial operations.
- Prior experience working in a biotechnology or pharmaceutical company coordinating and managing external projects at CROs.
- Excellent oral and written communication skills.
- Ability to work independently and collaboratively in a fast-paced, cross-functional, results-oriented team environment.
- Ability to work within tight timelines for successful and timely execution of project and program goals.
- Financial management of projects.
- Ability to travel, if required (Approximately 10%).
Preferred Qualifications
- PhD, PharmD, or equivalent in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, or a related field, with 6+ years of industry clinical pharmacology experience.
- Working knowledge of assay development and validation across molecular (e.g., qPCR, NGS), protein (e.g., ELISA, MSD, Luminex, HPLC), and immunological (e.g., multiparameter flow cytometry, immunohistochemistry) platforms.
- Experience working in gene therapies.
- Experience contributing to a BLA or MAA submission.
- Familiarity with biomarker and immunogenicity strategy.
Competencies
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
Senior Manager: Base pay range of $135,000 to $150,000+ bonus, equity and benefits
The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
See all 846+ Clinical Lead Jobs
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Get Access To All JobsTips for Finding Clinical Lead Jobs
Verify your licensure transfers
U.S. states issue their own clinical licenses, and your home country credentials won't automatically qualify you to practice. Research the specific endorsement or equivalency process for your discipline before applying to roles.
Target employers with a sponsorship track record
Large hospital systems, federally qualified health centers, and multi-site behavioral health organizations sponsor foreign workers far more consistently than small private practices. Filter your search toward employers with a documented H-1B filing history.
Understand the specialty occupation standard
H-1B approval for Clinical Lead roles depends on the position requiring at least a bachelor's degree in a specific clinical field. Roles with vague degree requirements or broad management responsibilities can draw additional USCIS scrutiny during adjudication.
Cap-exempt employers can bypass the lottery
Nonprofits affiliated with universities, teaching hospitals, and certain research institutions are exempt from the H-1B cap and annual lottery. Targeting these employers means sponsorship can start any time of year without waiting for the April selection cycle.
Align your degree to the clinical specialty
Your highest degree should directly correspond to the clinical area the role requires, whether that's nursing, social work, psychology, or another discipline. A mismatch between your degree field and the job's clinical focus is one of the most common H-1B denial triggers.
Factor in credential evaluation early
If your degree was earned outside the U.S., employers and USCIS will likely require a formal credential evaluation from a recognized agency. Starting this process early prevents delays after an offer is made and the sponsorship petition is being prepared.
Frequently Asked Questions
Which visa is most commonly used to sponsor Clinical Lead positions?
The H-1B visa is the primary visa for Clinical Lead sponsorship. The role must qualify as a specialty occupation, meaning it requires a theoretical and practical application of highly specialized knowledge in a specific clinical field. Some nonprofit and government-affiliated employers qualify as cap-exempt, which removes the lottery requirement and allows year-round filing.
Do I need a U.S. license to be sponsored as a Clinical Lead?
Yes, in most cases. Clinical Lead roles involve direct oversight of patient care or licensed practitioners, which means state licensure is typically a condition of employment and sometimes a USCIS requirement for the petition. The exact license required depends on your clinical discipline. You'll need to complete the state's endorsement or foreign credential review process, which varies significantly by state and profession.
How does USCIS evaluate Clinical Lead H-1B petitions specifically?
USCIS reviews whether the position genuinely requires a specific specialized degree, not just any bachelor's degree. For Clinical Lead roles, the clinical management or supervisory component can raise questions if USCIS views it as a general management position rather than a clinical specialty role. A strong petition includes a detailed job duties letter, the employer's organizational chart, and documentation showing the degree requirement is standard in the industry.
Can an O-1 visa work for a Clinical Lead role instead of H-1B?
It can, but the bar is high. The O-1A requires demonstrating extraordinary ability through evidence like awards, publications, peer review work, or a record of commanding a high salary relative to peers. Most Clinical Leads won't meet this standard unless they've achieved notable national or international recognition in their field. The H-1B is the more realistic path for the majority of applicants.
Where can I find Clinical Lead jobs that offer visa sponsorship?
Migrate Mate is built specifically for international job seekers and filters for employers actively willing to sponsor work visas. General job boards don't distinguish between employers open to sponsorship and those who aren't, which means significant time spent on applications that go nowhere. Migrate Mate removes that guesswork so you're only applying to roles with a real sponsorship pathway.
What is the prevailing wage requirement for sponsored Clinical Lead jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.