Principal Scientist / Senior Principal Scientist
IND-Enabling Drug Development — NIH-Funded Ebolavirus Therapeutics Program
Location: Carlsbad, California
Position: Full-time, on-site
Level: Principal Scientist or Senior Principal Scientist, depending on experience
About Arisan Therapeutics
Arisan Therapeutics is a science-driven biopharmaceutical company developing novel small-molecule therapeutics for serious infectious diseases and other areas of major unmet medical need.
We recently received a multiyear NIH/NIAID DMID contract to advance ARN-75092, a next-generation oral, broad-spectrum small-molecule ebolavirus therapeutic, through preclinical and IND-enabling development, regulatory submission, and an initial Phase 1 clinical study.
This program expands Arisan’s hemorrhagic-fever platform, which also includes a government-supported Phase 2 Lassa fever antiviral program. The company is also evaluating the repurposing of a clinical-stage compound for metabolic disorders.
Arisan is a small, highly focused organization where experienced scientists work directly with company leadership and can have a visible and substantial impact on program execution and company success.
The Opportunity
Arisan is seeking a highly capable, self-motivated Principal Scientist or Senior Principal Scientist with significant experience in preclinical and IND-enabling small-molecule drug development.
Our areas of greatest interest, in priority order, are:
- Safety pharmacology and nonclinical toxicology
- CMC and pharmaceutical development
- DMPK, ADME, bioanalysis, and PK/PD
The successful candidate will provide scientific and operational leadership for major components of the ARN-75092 development program. Deep expertise in at least one of the areas above is required, together with a working understanding of cross-functional drug development and the requirements for advancing a candidate through IND submission and into Phase 1.
The position combines scientific leadership with external-study oversight, regulatory support, technical writing, program planning, budget and timeline management, and communication with internal and external stakeholders.
Depending on experience, the individual may serve as program manager, deputy program manager or scientific counterpart for the NIH/DMID contract.
This is a hands-on role for someone who thrives in a small-company environment, works effectively with limited supervision, and is comfortable assuming responsibilities beyond a narrowly defined scientific specialty.
Key Responsibilities
Scientific and Development Leadership
- Provide scientific leadership for one or more components of the ARN-75092 preclinical and IND-enabling development program.
- Develop and critically review study strategies, protocols, data, reports, and development plans.
- Integrate findings across toxicology, safety pharmacology, CMC, DMPK, virology, regulatory, and clinical-readiness activities.
- Proactively identify scientific, regulatory, quality, vendor, budget, and schedule risks and recommend practical, data-driven solutions.
- Help ensure that development activities meet appropriate scientific, GLP, FDA, ICH, contractual, and quality expectations.
- Contribute relevant expertise to Arisan’s Lassa fever and metabolic-development programs as needed.
External Study and Vendor Oversight
- Lead selected external studies from vendor and proposal evaluation through protocol development, execution, data interpretation, and final-report review.
- Serve as a scientific lead for CROs, CDMOs, consultants, academic collaborators, and government-supported facilities.
- Monitor study quality, scope, cost, timelines, and deliverables.
- Review vendor proposals and proactively identify and resolve study, vendor, financial, or scheduling issues before they affect program budgets or milestones.
IND and Regulatory Support
- Contribute to the overall IND-enabling and regulatory strategy.
- Ownership of expertise-area IND and Investigator’s Brochure content, regulatory briefing packages responses and meeting preparation.
- Help ensure that studies, reports, and regulatory materials are complete, internally consistent, scientifically accurate, and suitable for submission.
Program, Budget, and Timeline Management
- Develop or support integrated program plans and translate scientific and regulatory strategy into executable work plans with clear responsibilities, study schedules, deliverables, dependencies, critical paths, and risk assessments.
- Manage or support study and program budgets, including vendor-proposal review, forecasting, tracking expenditures, invoice review, and early identification of potential cost overruns.
- Monitor cross-functional dependencies and identify and communicate unanticipated delays, resource constraints, and critical-path risks.
- Depending on experience, assume broader responsibility for program and contract management.
Reporting, Writing, and Communication
- Support or lead preparation of DMID monthly technical reports, milestone documentation, program reviews, development updates, and presentations.
- Draft, review, and edit clear, accurate, and high-quality scientific and technical documents.
- Prepare presentations for DMID, FDA, company leadership, collaborators, and other stakeholders.
- Communicate complex scientific, regulatory, operational, financial, and scheduling issues clearly to both technical and nontechnical audiences.
- Lead or participate in cross-functional meetings and ensure clear decisions, action items, ownership, deadlines, and accountability.
Required Qualifications
- PhD, PharmD, DVM, MD, or equivalent advanced degree in toxicology, pharmacology, pharmaceutical sciences, chemistry, biology, or a related discipline or MS with substantial directly relevant industry and IND-enabling leadership experience.
- Significant biotechnology or pharmaceutical industry experience in preclinical drug development.
- Demonstrated experience advancing a small-molecule candidate through IND-enabling development.
- Strong expertise in at least one of the following:
- Safety pharmacology or nonclinical toxicology
- CMC or pharmaceutical development
- DMPK, ADME, bioanalysis, toxicokinetics, or PK/PD
- Experience designing, overseeing, interpreting, and reporting studies conducted by CROs, CDMOs, or other external collaborators.
- Working knowledge of GLP requirements and applicable FDA and ICH expectations.
- Experience contributing to INDs, FDA submissions, regulatory briefing packages, or related development documents.
- Exceptional scientific writing, editing, presentation, and oral communication skills.
- Ability to communicate complex issues clearly to scientific, government, regulatory, executive, and external-partner audiences.
- Strong analytical judgment, organizational ability, initiative, accountability, and attention to detail.
- Ability to manage multiple priorities and work effectively with limited supervision in a small, fast-moving organization.
- Ability and willingness to work full-time and on-site at Arisan’s Carlsbad facility.
Strongly Desired Qualifications
- Previous experience leading external vendors, consultants, CROs, CDMOs, and academic collaborators.
- Experience managing cross-functional team dependencies, drug-development timelines, milestones and critical paths.
- Prior leadership responsibility for a successful IND-enabling program or IND submission.
- Experience working effectively in a small or emerging biotechnology company.
- Experience spanning more than one of Arisan’s priority scientific disciplines.
- Experience with antiviral, infectious-disease, biodefense, or medical countermeasure development.
- Experience developing or managing study and program budgets, reviewing vendor proposals, forecasting costs, tracking expenditures and evaluating change orders.
- Experience with government-funded drug-development programs and familiarity with government technical reports, milestone documentation, and program presentations.
The Successful Candidate
The strongest candidate will be scientifically rigorous, highly accountable, proactive, and comfortable combining scientific leadership with operational execution. The individual will be an exceptional writer and effective presenter who can manage vendors, budgets, timelines, and competing priorities while maintaining scientific and regulatory quality.
The successful candidate will be collaborative across disciplines, able to make sound decisions, skilled at recognizing risks early, and willing to take ownership beyond a narrowly defined functional role.
Why Join Arisan
- Join a mission-driven organization where individual expertise, judgment, and execution can have an unusually high impact on scientific strategy, study execution, regulatory planning, budgets, timelines, and program decisions.
- Help advance a next-generation oral, broad-spectrum ebolavirus therapeutic through IND and into Phase 1, while contributing to clinical-stage hemorrhagic-fever and emerging metabolic-development programs.
- Work directly with company leadership, NIH/DMID, FDA-facing consultants, CROs, CDMOs, and leading infectious-disease investigators.
Compensation and Benefits
- Salary range: $150,000–$205,000, commensurate with experience and scope of responsibility
- Company incentive stock option plan
- Health insurance coverage
- 401(k) retirement plan with company matching
- Paid time off and company holidays
Arisan Therapeutics is an equal-opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other status protected
Pay: $150,000.00 - $205,000.00 per year
Benefits:
- 401(k)
- Flexible schedule
- Relocation assistance
- Retirement plan
Work Location: In person
