Provide senior clinical oversight and direction for the review of NDA and/or BLA clinical components, including clinical summaries, integrated analyses, and supporting study documentation * Lead the ...
Provide senior clinical oversight and direction for the review of NDA and/or BLA clinical components, including clinical summaries, integrated analyses, and supporting study documentation * Lead the ...
This position is responsible for leading, characterizing and validating purification processes, as well as authoring IND/BLA sections to support our large molecule pipeline. Key Accountabilities ...
This position is responsible for leading, characterizing and validating purification processes, as well as authoring IND/BLA sections to support our large molecule pipeline. Key Accountabilities ...
Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies. * RA support in interactions with Health ...
Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies. * RA support in interactions with Health ...
Author and review relevant CMC documentation including PV protocols/reports and regulatory sections (e.g., BLA, IND amendments). * Develop and execute strategies for process performance qualification ...
Author and review relevant CMC documentation including PV protocols/reports and regulatory sections (e.g., BLA, IND amendments). * Develop and execute strategies for process performance qualification ...
Principal Scientist, Late Stage Upstream Process Development (San Francisco, CA)
San Francisco, CA · On-site
Author and review relevant CMC documentation including PV protocols/reports and regulatory sections (e.g., BLA, IND amendments). * Develop and execute strategies for process performance qualification ...
Principal Scientist, Late Stage Upstream Process Development (San Francisco, CA)
San Francisco, CA · On-site
Author and review relevant CMC documentation including PV protocols/reports and regulatory sections (e.g., BLA, IND amendments). * Develop and execute strategies for process performance qualification ...
Assistant General Manager - Hotel
Lincoln, RI · On-site
Quality Management - Assists in achieving BLA minimum scoring standard on all Brand Quality Assurance inspections. Must maintain 80% or higher on Franchise product quality scoring. Inspect rooms and ...
Assistant General Manager - Hotel
Lincoln, RI · On-site
Quality Management - Assists in achieving BLA minimum scoring standard on all Brand Quality Assurance inspections. Must maintain 80% or higher on Franchise product quality scoring. Inspect rooms and ...
The ideal candidate brings deep regulatory experience-particularly IND and BLA submissions-strong people leadership, and a proven ability to scale analytical organizations in fast-paced biotech ...
The ideal candidate brings deep regulatory experience-particularly IND and BLA submissions-strong people leadership, and a proven ability to scale analytical organizations in fast-paced biotech ...
Quality Management - Assists in achieving BLA minimum scoring standard on all Brand Quality Assurance inspections. Must maintain 80% or higher on Franchise product quality scoring. Inspect rooms and ...
Quick apply
Quality Management - Assists in achieving BLA minimum scoring standard on all Brand Quality Assurance inspections. Must maintain 80% or higher on Franchise product quality scoring. Inspect rooms and ...
This role leads all biometrics contributions to late-stage clinical development, BLA and NDA submissions, and health authority interactions, ensuring delivery of high-quality, submission-ready ...
This role leads all biometrics contributions to late-stage clinical development, BLA and NDA submissions, and health authority interactions, ensuring delivery of high-quality, submission-ready ...
CMC Writer
Paramus, NJ · On-site
Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.
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CMC Writer
Paramus, NJ · On-site
Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.
... BLA, IND amendments). Develop and execute strategies for process performance qualification (PPQ) and continued process verification (CPV). Collaborate cross-functionally with MSAT, Downstream ...
... BLA, IND amendments). Develop and execute strategies for process performance qualification (PPQ) and continued process verification (CPV). Collaborate cross-functionally with MSAT, Downstream ...
Remote | Pharmaceutical Research & Development Consultant -- $65-$90/hour
New York, NY · On-site +1
$65 - $90/hr
Review regulatory and CMC scenarios involving IND, NDA, BLA, EMA materials, CMC technical reports, quality documentation, safety materials, and submission workflows * Support structured review of ...
Quick apply
Remote | Pharmaceutical Research & Development Consultant -- $65-$90/hour
New York, NY · On-site +1
$65 - $90/hr
Review regulatory and CMC scenarios involving IND, NDA, BLA, EMA materials, CMC technical reports, quality documentation, safety materials, and submission workflows * Support structured review of ...
This role leads all biometrics contributions to late-stage clinical development, BLA and NDA submissions, and health authority interactions, ensuring delivery of high-quality, submission-ready ...
This role leads all biometrics contributions to late-stage clinical development, BLA and NDA submissions, and health authority interactions, ensuring delivery of high-quality, submission-ready ...
Lead/support authoring and reviewing of relevant module 3 sections of regulatory submissions (IND, IMPD, BLA, etc.), along with, if necessary, responding to information requests and interfacing with ...
Lead/support authoring and reviewing of relevant module 3 sections of regulatory submissions (IND, IMPD, BLA, etc.), along with, if necessary, responding to information requests and interfacing with ...
Contribute to the preparation of the pre-IND, IND, IB and NDA/BLA documents * Responsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis software * Contribute ...
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Contribute to the preparation of the pre-IND, IND, IB and NDA/BLA documents * Responsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis software * Contribute ...
Lead BLA end-to-end test strategy and coordination across initiatives * Define E2E validation scope and ensure coverage of customer-facing digital journeys * Coordinate testing activities across ...
Lead BLA end-to-end test strategy and coordination across initiatives * Define E2E validation scope and ensure coverage of customer-facing digital journeys * Coordinate testing activities across ...
Assistant or Associate Professor of Practice in Landscape Architecture (Multiple Positions)
White Hall, AR · On-site
The successful candidates will also be considered for program coordinator roles (BLA or MLA). We seek candidates with teaching expertise in one or more of the following areas: * Design Foundations
Assistant or Associate Professor of Practice in Landscape Architecture (Multiple Positions)
White Hall, AR · On-site
The successful candidates will also be considered for program coordinator roles (BLA or MLA). We seek candidates with teaching expertise in one or more of the following areas: * Design Foundations
Lead BLA end-to-end test strategy and coordination across initiatives * Define E2E validation scope and ensure coverage of customer-facing digital journeys * Coordinate testing activities across ...
Lead BLA end-to-end test strategy and coordination across initiatives * Define E2E validation scope and ensure coverage of customer-facing digital journeys * Coordinate testing activities across ...
Lead BLA end-to-end test strategy and coordination across initiatives * Define E2E validation scope and ensure coverage of customer-facing digital journeys * Coordinate testing activities across ...
Lead BLA end-to-end test strategy and coordination across initiatives * Define E2E validation scope and ensure coverage of customer-facing digital journeys * Coordinate testing activities across ...
Drive execution against key milestones including design verification and qualification, process validation (PPQ), BLA submission, and launch readiness * Serve as the primary technical liaison between ...
Drive execution against key milestones including design verification and qualification, process validation (PPQ), BLA submission, and launch readiness * Serve as the primary technical liaison between ...
Bla information
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$29.5K - $40.8K
11% of jobs
$50.5K is the 25th percentile. Wages below this are outliers.
$40.8K - $52K
17% of jobs
$52K - $63.3K
14% of jobs
The median wage is $74K / yr.
$63.3K - $74.6K
9% of jobs
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2% of jobs
$97.1K - $108.4K
1% of jobs
$114.7K is the 75th percentile. Wages above this are outliers.
$108.4K - $119.7K
23% of jobs
$119.7K - $131K
3% of jobs
$131K - $142.2K
5% of jobs
$142.2K - $153.5K
6% of jobs
$29.5K
$85.1K
$153.5K
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What is the difference between Bla vs Data Analyst?
| Aspect | Bla | Data Analyst |
|---|---|---|
| Required Credentials | Typically requires a degree in a related field, sometimes certifications in specific tools | Bachelor's degree in statistics, computer science, or related field; certifications like Microsoft Excel or SQL are common |
| Work Environment | Often in office settings, collaborating with teams on projects | Office-based, working with data sets, reporting, and analysis tasks |
| Employer & Industry Usage | Used across various industries including tech, finance, healthcare | Commonly employed in finance, marketing, healthcare, and tech sectors |
| Common Search & Comparison Intent | People compare Bla to Data Analyst to understand roles, skills, and career paths |
The comparison between Bla and Data Analyst shows that both roles often require similar educational backgrounds and work environments. While Bla may have specific industry nuances, both roles are integral in data-driven decision-making across multiple sectors. Understanding these differences helps job seekers identify the right career path and required skills.
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$30/hr
Full-time
Medical, Dental, Vision, Retirement
Posted 7 days ago
Job description
The successful candidate will drive programs from early clinical development through key regulatory and development inflection points, ensuring alignment between clinical strategy, data generation, and regulatory expectations. This role requires a leader who thrives in a start-up environment, operates comfortably at both a strategic and executional level, and is willing to roll up their sleeves to solve complex clinical and regulatory challenges as the organization grows. This is a remote-based position located in the United States.
Responsibilities:
- Lead the overall clinical development strategy for oncology programs with primary focus on cholangiocarcinoma and hepatocellular carcinoma from early development through late-stage and registration-enabling studies
- Develop and execute integrated clinical development plans aligned with regulatory objectives including study protocol design, execution, and data analysis/interpretation, in conjunction with other relevant functional leaders
- Direct study design, protocol development, and execution for Phase 1-3 clinical trials, including pivotal registrational cancer studies
- Provide expert oversight of clinical data analysis and interpretation, ensuring data are robust, clinically meaningful, and suitable to support regulatory decision-making
- Contribute to pipeline strategy and diligence for new internal and external oncology opportunities, providing senior clinical and regulatory development input
- Serve as a clinical development lead for global regulatory interactions, working in close partnership with Regulatory Affairs to define strategy and messaging
- Lead and actively participate in meetings with regulatory agencies (e.g., FDA, EMA, MHRA), including scientific advice, End-of-Phase, pre-NDA/BLA, and ad hoc regulatory interactions, from a clinical development perspective
- Provide senior clinical oversight and direction for the review of NDA and/or BLA clinical components, including clinical summaries, integrated analyses, and supporting study documentation
- Lead the clinical development contribution to responses to health authority questions, including written responses to information requests, major review questions, and post-submission clarifications
- Ensure that clinical strategy, trial design, and data presentation are aligned with evolving regulatory guidance and agency feedback throughout the product lifecycle
- Ensure the quality, consistency, and regulatory readiness of all clinical documents, including Investigators' Brochures, protocols, CSRs, safety narratives, and submission-critical documents
- Provide senior scientific and clinical input into study-related documentation, including ICFs, CRFs, SAPs, clinical pharmacology analysis plans, and data interpretation narratives
Requirements
- MD strongly preferred; advanced scientific degree (PhD, PharmD) considered with substantial relevant clinical development experience
- 10-15+ years of clinical development experience in biotech or pharmaceutical industry, with a strong focus in oncology
- Direct experience in liver cancers (HCC, cholangiocarcinoma) strongly preferred
- Experience in start-up or emerging biotech setting preferred
- Demonstrated experience in late-stage development and regulatory submission support, including clinical leadership for NDA and/or BLA filings and responses to health authority feedback
- Proven ability to lead regulatory interactions from a clinical development perspective and translate agency feedback into actionable development plans
- Deep understanding of GCP, ICH, FDA, and global regulatory requirements, oncology trial design, and interpretation of complex clinical datasets
- Experience operating successfully in a start-up or emerging biotech environment strongly preferred
- Strong track record of building and leading multidisciplinary clinical teams and influencing cross-functionally
- Demonstrated commitment to ethics, patient safety, and scientific rigor, with ability to represent the company credibly in internal and external settings
- Ability to prioritize effectively and perform in a fast-paced, remote, and rapidly evolving environment with a hands-on, "get-it-done" mindset
- Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion with a commitment to putting patients first
The anticipated annual base salary range for this role is $300,000 to $450,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.
#LI-REMOTE
About Elevar Therapeutics
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
11 - 50 Employees
Headquarters location
Salt Lake City, UT, US
Year founded
2005