Access to Advanced Health Institute is a Seattle-based nonprofit biotech institute that is undergoing a transformation to lead a global coalition to fight infectious disease and address health disparities and inequities worldwide. We think it’s unfair that where a person lives or how much money they make dictates their access to life-changing medicine. We’re looking for people who want to join us in increasing accessibility to tools that harness the immune system and allow a healthy life, free of illness and disease, regardless of geography or socio-economic status – from compassion and collaboration come change.
We will serve as a center for innovation and collaboration in vaccine and cancer immunotherapy research and development, early-phase GMP manufacturing, and training the next generation of scientists and manufacturing teams to achieve our mission. This is where the high-quality science of an academic research organization and the product-development capabilities of a biotech company meet.
Summary
As a Principal Scientist, you will play a critical role in advancing our RNA vaccine candidates from preclinical research to phase 2 clinical trials. Working under the Director of the RNA Program and closely with the CEO, you will collaborate with cross-functional teams, including research, manufacturing, product development, clinical development, and regulatory affairs to ensure successful RNA vaccine development. Your expertise will be instrumental in achieving regulatory milestones and ultimately bringing safe and effective vaccines to patients worldwide.
Responsibilities
Vaccine Development Strategy:
- With the Director, RNA Program and AAHI Senior Scientific Leadership, develop and execute a comprehensive strategy for advancing vaccine candidates from preclinical stages through phase 2 clinical trials.
- Collaborate with internal stakeholders to align development plans with corporate goals, external partner/funder demands, and regulatory requirements.
- Identify project risks, maintain a project risk register, design and implement risk mitigation strategies.
Preclinical Research Oversight:
- Work closely with preclinical study leads, both internal and external, to design IND-enabling preclinical animal studies.
- Communicate plans for key preclinical studies for funders/stakeholders, documenting study design approvals, key decisions, and deviations from the approved plans.
Product Developmentand Manufacturing:
- Interact with cross-functional teams (Product Development, Quality Control, Quality Assurance, Manufacturing, Clinical Regulatory) downstream to successfully push products forward.
- Serve as a central information source, identifying and enabling appropriate cross-team communication as needed to advance complex cross-functional vaccine development projects.
- Work closely with department managers to develop and maintain appropriate timelines; work with QC/MFG schedules to deliver orders on time and efficiently with quality.
Regulatory Affairs and IND Application:
- Oversee the quality and collection of preclinical and manufacturing reports, documents, and data in preparation for submission of the Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).
Clinical Trial Design and Execution:
- Work with Clinical / Regulatory team to assure that candidate vaccines are ready for phase 1 and phase 2 clinical trials, providing technical and contractual input on study designs, timelines, and desirable outcomes.
Collaboration and Leadership:
- Foster strong relationships with internal and external stakeholders, including academic institutions, contract research organizations (CROs), regulatory authorities, and project sponsors.
- Provide scientific leadership within the vaccine development team.
- Working as a team with project managers, PIs, and department leads, develop project risk registers to develop and enact risk mitigation/management plans.
Data Analysis and Reporting:
- Analyze clinical trial data, interpret results, and contribute to study reports.
- Present findings to senior management and participate in regulatory interactions.
Requirements
- Ph.D. in a relevant scientific discipline (e.g., immunology, virology, microbiology, or related field).
- Minimum of 8 years of experience in vaccine development, including hands-on involvement in preclinical and clinical stages, with direct experience working for a commercial vaccine developer.
- Strong understanding of regulatory requirements for vaccine development, including IND submissions.
- Excellent written and verbal communication skills.
- Ability to collaborate effectively across multidisciplinary teams.
- Proven track record of successful vaccine development projects.
Benefits
We offer a comprehensive compensation plan which includes:
- Medical, Dental, Vision with 90% employer covered premiums for you & dependents
- Group Life, AD&D, Short & Long-term disability, Hospital Indemnity, Accident
- Flexible Spending Accounts (Medical and Dependent Care)
- Employer funded HSA
- Matching 401(k) Retirement Plan
- Commuter benefits
- Employee Assistance Plan (EAP)
- Up to 2 months paid time off per year
- Up to 6 weeks' Vacation & Sick pay
- 11 paid holidays
- End of year weeklong shutdown (last week of December)
- Flexible work schedule
- Paid Mindfulness/Fitness App
- Discount Marketplace
- Identify Theft & Travel Protection
- Group Workouts
We do not discriminate. We are an equal opportunity employer and are committed to inclusion and encourage everyone to bring their full selves to work. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. We are an E-Verify Employer.
Please contact us if you don’t apply through our website and want to complete an EEOC Voluntary Form.