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DIRECTOR REGULATORY AFFAIRS

Classification:    Salaried/Exempt


About Curevo Vaccine
Curevo Vaccine was founded in 2018 to develop innovative vaccines in partnership with GC Pharma and Mogam Institute for Biomedical Research. The goal of Curevo Vaccines is to support GC Pharma’s vaccine development activities, which are targeted at making and commercializing new-generation vaccines using a proprietary adjuvanted subunit vaccine technology. We are a clinical-stage biotechnology company located in Seattle, WA.

OVERVIEW

We are seeking an experienced Director, Regulatory Affairs who will be responsible for defining the vision and clinical strategies that will support meeting Curevo’s vaccine development and commercialization objectives:

  • Developing, implementing, and advising on global regulatory strategies to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders.
  • Focusing on the strategic translation of business objectives into clinical requirements for clinical trials, quality audits, and meeting regulatory requirements for clinical evaluations and post-market surveillance.

The Director, Regulatory Affairs is responsible for the management of clinical regulatory applications (domestic and international) in support of Curevo’s multiple phase clinical trials in development. The role requires working closely with Curevo’s clinical teams, partners, consultants, contract research organizations, local and global health authorities to ensure rapid review and approval of IND, clinical trial applications, and other regulatory filings. This position is also responsible for obtaining and interpreting regulations and guidance and providing regulatory advice to clinical and CMC departments. Strong communication and management skills are required. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and subject matter experts.

ESSENTIAL RESPONSIBILITIES & DUTIES
  • Oversee planning, preparation, and submission of the clinical documents (e.g., protocol amendments, investigator brochures, etc.) maintain IND and clinical trial applications globally (e.g., annual report). Ensure that the sections are complete, well-written, and meet all relevant regulatory requirements.
  • Review, evaluate, and compile document packages for regulatory submissions ensuring compliance with the FDA or other regulatory authorities.
  • Develop excellent relationships with external consultant groups, contract research organizations, and Curevo partners.
  • Provide regulatory advice to clinical operations and CMC departments based on knowledge of current regulatory requirements.
  • Manage interactions with FDA or other regulatory authorities for assigned projects.
  • Respond to agency questions and requests for information.
EXPERIENCE

At least 10 years of experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry

Expertise in complex biologics, vaccines is required.

SKILLS
  • Experience in filing INDs and CTAs for pharmaceutical, vaccine or biologic products in the US and/or Europe is required.
  • Knowledge of cGCP (FDA, ICH, and ISO) requirements and FDA regulatory guidelines
  • Thorough understanding of relevant drug development regulations and guidelines
  • Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs.
  • Strong analytical skills, problem solving ability and presentation skills required.
  • Flexibility, independence, and ability to prioritize and manage multiple tasks simultaneously.
  • Ability to work independently in a dynamic and changing company environment.
REQUIREMENTS

BS/MS degree in related discipline required.

PHYSICAL DEMANDS

Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with hands and arms.  Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for entire work shifts. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Physically able to use and operate equipment used in clinical research and trials. Ability to lift, tug, and pull up to 50 lbs.

WORK ENVIRONMENT

This job operates in a professional office environment.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

ADDITIONAL INFORMATION
  • As part of our standard hiring process for new employees, employment with Curevo Vaccine requires pre-employment references, background checks and drug testing.

APPLICATION INSTRUCTIONS
Please submit a resume and cover letter to jobs@curevovaccine.com  with the position title in the subject title. Alternatively, you may attach a combined PDF of your documents in the fill-in space at the bottom of our website careers page.

About Curevo Vaccine
Curevo Vaccine was founded in 2018 to develop innovative vaccines in partnership with GC Pharma and Mogam Institute for Biomedical Research. The goal of Curevo Vaccines is to support GC Pharma’s vaccine development activities, which are targeted at making and commercializing new-generation vaccines using a proprietary adjuvanted subunit vaccine technology. We are a clinical-stage biotechnology company located in Seattle, WA.

Curevo Vaccine is a proud Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

MANAGER REGULATORY AFFAIRS

Classification:    Salaried/Exempt


About Curevo Vaccine
Curevo Vaccine was founded in 2018 to develop innovative vaccines in partnership with GC Pharma and Mogam Institute for Biomedical Research. The goal of Curevo Vaccines is to support GC Pharma’s vaccine development activities, which are targeted at making and commercializing new-generation vaccines using a proprietary adjuvanted subunit vaccine technology. We are a clinical-stage biotechnology company located in Seattle, WA.

OVERVIEW

Responsible for regulatory activities supporting the development of vaccine candidates in the US and Internationally.

General Requirements - Adhere to all Legislative/Health Authority Requirements pertaining to Company’s products, Standard Operating Procedures, Good Clinical Practice Principles (ICH/GCP), Human Subjects Protection, and Company Policies. 

ESSENTIAL RESPONSIBILITIES & DUTIES
  • Responsible for regulatory activities supporting the development of vaccine candidates in the US and Internationally.
  • Manage regulatory projects and submissions for vaccine candidates.
  • Ensure that all necessary applications are filed and maintained in compliance with applicable regulations.
  • Lead and direct the work of our partner organizations and consultants.
  • Provide regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development and associated regulations.
  • Collaborate with relevant partners to ensure global regulatory alignment for all projects within area of responsibility.
  • Assist Clinical Operations or lead other Curevo tasks as required.
  • Coordinate and accountable for all Health Authority submissions and approvals within area of responsibility.
  • Has a quality focus so that submissions are right-first-time.
  • Act as primary regulatory authority contact for projects of responsibility.
  • Coordinate interactions with and submissions to FDA. Communicate effectively the outcome of Health Authority interactions and provide analyses of potential impact.  
  • Ensure compliance with both internal Curevo process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
  • Act as US and International regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the US and Internationally. Provide a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
  • Accountable for overall content and management of local regulatory components and filings i.e. NDA/BLAs, INDs. Contribute to overall strategy and content for local label development.
  • Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
  • Actively participate as member of Curevo supporting product and new business development.
  • Responsible for US and International specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.
  • Lead and manage health authority meetings as applicable for specified projects.
  • Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.
  • Any other duties as assigned.
REQUIREMENTS
  • Bachelor’s Degree in Life Sciences (B.S. or B.A.), Pharmacy or Medicine required.
  • Minimum of 5+ years’ experience in Regulatory Affairs. Prior experience in pharmaceutical or biotech environment and/or clinical vaccine research is highly desirable.
  • Experience in managing regulatory affairs projects required; experience with biologics preferred.
  • Thorough understanding of the FDA and other regulatory agencies.
  • Demonstrated ability to be comfortable working in a complex, fast-moving and busy work environment.
  • Willing to perform wide range of duties in a smaller organization on an independent level and as a team player.
  • Excellent oral and written communication skills; ability to communicate effectively with co-workers and Health Authorities.
  • Proficiency in MS Office [Excel, Word, PowerPoint, MS Project] and Adobe Acrobat.
  • Strong working knowledge of medical/scientific terminology.
  • Knowledge of eCTD desirable.
  • Able to travel as required by projects (10-25% time; US and international).
PHYSICAL DEMANDS

Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with hands and arms.  Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for entire work shifts. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Physically able to use and operate equipment used in clinical research and trials. Ability to lift, tug, and pull up to 50 lbs.

WORK ENVIRONMENT

This job operates in a professional office environment.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

ADDITIONAL INFORMATION
  • As part of our standard hiring process for new employees, employment with Curevo Vaccine requires pre-employment references, background checks and drug testing.

APPLICATION INSTRUCTIONS
Please submit a resume and cover letter to jobs@curevovaccine.com  with the position title in the subject title. Alternatively, you may attach a combined PDF of your documents in the fill-in space at the bottom of our website careers page.

About Curevo Vaccine
Curevo Vaccine was founded in 2018 to develop innovative vaccines in partnership with GC Pharma and Mogam Institute for Biomedical Research. The goal of Curevo Vaccines is to support GC Pharma’s vaccine development activities, which are targeted at making and commercializing new-generation vaccines using a proprietary adjuvanted subunit vaccine technology. We are a clinical-stage biotechnology company located in Seattle, WA.

Curevo Vaccine is a proud Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

CLINICAL TRIAL ASSOCIATE

Classification:    Salaried/Exempt
Reports to:        Head of Clinical Operations (with Supervision by Clinical Operations Manager)

 

About Curevo Vaccine
Curevo Vaccine was founded in 2018 to develop innovative vaccines in partnership with GC Pharma and Mogam Institute for Biomedical Research. The goal of Curevo Vaccines is to support GC Pharma’s vaccine development activities, which are targeted at making and commercializing new-generation vaccines using a proprietary adjuvanted subunit vaccine technology. We are a clinical-stage biotechnology company located in Seattle, WA.

 

OVERVIEW

The CTA will assist with clinical trial planning and execution activities and assist in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.

  • Support the Clinical Operations teams in study start up, execution, and closeout.
  • Provide general administrative support to the clinical operations team and may act as a central contact for designated project communications, correspondence, and associated documentation.
  • Create and/or maintains various clinical tools such as use of electronic CTMS systems or other electronic software/cloud systems to track data including, but not limited to study enrollment, study team contact lists, study team training, IRB applications, consent/re-consents at site, IP shipment tracking and laboratory sample tracking.
  • Assist with the creation of PowerPoint slides for activities such as Site Initiation Visit presentations, Investigator Meetings, and other study related team trainings, or other presentations as assigned.
  • Preparation of clinical operations meeting minutes.
  • Collaborate with Clinical Trial Managers, Clinical Research Associates, and Contract Research Organizations (CRO) to support ongoing trial monitoring activities.
  • Ensure Inspection Readiness by managing the set-up, maintenance, and quality control of the internal Trial Master Files (eTMF) and overseeing the CRO’s management of Trial Master Files.
  • Manages the Clinical Operational internal document filing system and documents.
  • Contributes to the preparation of trial-related materials (Clinical Protocols, Informed Consent Forms, Case Report Forms, Standard Operating Procedures, Monitoring Plans, Laboratory Manuals, Pharmacy Manuals, Study Reference Manuals, Diaries, CRFs).
  • Assist project teams with study specific documentation and guidelines as appropriate.
  • Assist in the coordination and tracking of IP supply, lab supplies and clinical research specimen shipments.
  • Assist with tracking of IP supply at depo and clinical sites and escalates any issues to management.
  • Responsible for tracking the inventory of clinical research specimens.
  • Assist with planning, preparation, and on-site support of investigators meetings.
  • Actively order and maintain ancillary clinical study supplies required for conduct of clinical trials.
  • Coordinate logistics for clinical project meetings and preparation and distribution of meeting minutes.
  • Ensure timely completion of study tasks and update trial trackers on an on-going basis.
  • Generate and distribute study newsletters.
  • Maintain version and quality control of study documentation and submit to TMF.
  • Proactively identify, triage, and coordinate resolution of clinical study issues.
  • Assist with ensuring Clinical Operations Team is up to date on ICH GCP regulations and revisions.
  • Assist in quality control audits of clinical study documentation (e.g., Sites regulatory binder, source documentation, Monitoring visit reports, etc.).
  • Assist in reviewing data entered in EDC by comparing to source documents, issuing, and resolving queries in EDC.
  • Copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
  • Assist in coordination of Investigator payments or resolving discrepancies, if applicable.
  • Assist in the tracking and distribution of safety reports.
  • Coordinate document translation with assigned vendor, if required.
  • Assist with the coordination of team member training tracking.
  • Actively participate in process improvement
  • Other duties as assigned.

 

REQUIREMENTS

  • Degree in Nursing (R.N. or B.S.N), Life Sciences (B.S. or B.A.), Pharmacy or Medicine required
  • CCRA/CCRP certification preferred.
  • Minimum of 2+ years’ experience in clinical research or other regulated environment. Prior experience in small biotech environment, CRO, and/or clinical vaccine research clinical site is highly desirable.
  • Understanding of clinical trial site monitoring desired
  • Strong attention to detail and accuracy
  • Thorough understanding of ICH, and GCP regulations, guidelines, policies, and practices for conducting clinical trials.
  • Knowledge of FDA 21 CFR Part 11 for Handling of Electronic Records
  • Ability to always maintain and exhibit discretion when handling confidential information.
  • Demonstrated ability to be comfortable and flexible working in a complex, fast-moving, and busy work environment.
  • Willing to perform wide range of duties in a smaller organization on an independent level and as a team player.
  • Excellent oral and written communication skills; ability to communicate effectively with co-workers and clinical site personnel.
  • Proficiency in MS Office [Excel, Word, PowerPoint,] and Adobe Acrobat. Experience with project management software or cloud systems (i.e., Smartsheet or Airtable) a plus.
  • Strong working knowledge of medical/scientific terminology.
  • Prior experience of clinical trial e-systems preferred (e.g., EDC (Electronic Data Capture), eSource, eISF (Investigative Site File), and/or CTMS systems preferred.
  • Able to travel as required by projects (approx. 10% time as needed: US and international).
  • This is not a remote position.

 

PHYSICAL DEMANDS

Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with hands and arms.  Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for entire work shifts. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Physically able to use and operate equipment used in clinical research and trials. Ability to lift, tug, and pull up to 50 lbs.

 

WORK ENVIRONMENT

This job operates in a professional office environment.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

 

APPLICATION INSTRUCTIONS

Please submit a resume and cover letter to jobs@curevovaccine.com  with the position title in the subject title. Alternatively, you may attach a combined PDF of your documents in the fill-in space at the bottom of our website careers page.

 

Curevo Vaccine is a proud Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

CMC OPERATIONS MANAGER

About Curevo Vaccine
Curevo Vaccine was founded in 2018 to develop innovative vaccines in partnership with GC Pharma and Mogam Institute for Biomedical Research. The goal of Curevo Vaccines is to support GC Pharma’s vaccine development activities, which are targeted at making and commercializing new-generation vaccines using a proprietary adjuvanted subunit vaccine technology. We are a clinical-stage biotechnology company located in Seattle, WA.

 

OVERVIEW

The CMC Operations Manager will drive the CMC program in development and scale up, including tech transfer, material management, planning, timeline, and budgets. Curevo is an innovative biotech looking for a CMC manager with robust experience in CMC process development and cGMP manufacturing knowledge. This individual will be expected to collaborate with Regulatory, Clinical Operations and Program Management departments across Curevo to ensure operational activities are in line with business strategy. Their focus will be on bringing in the right culture to their team and they will want to move FAST. The CMC Operations Manager plays a critical role in developing the CMC Operations Infrastructure, and managing relationships with external CMOs. They may also contribute to the process of New Drug submissions to the IND and in creating policies and procedures to ensure compliance with US Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211).

 

ESSENTIAL RESPONSIBILITIES & DUTIES

  • Experience with development and writing of CMC-related documents
  • Strong understanding of regulatory guidance as it applies to CMC submissions (e.g., NDAs, MAAs, INDs, IMPDs)
  • Interpret and analyze quality data related to product characterization, manufacturing process, product and process control, and stability
  • Experience in tech transfer to CDMO, scale up and gap analysis
  • Ability to complete documents according to sponsor's format, processes, and regulatory guidelines
  • Lead projects independently with minimal oversight
  • Interpret and analyze applicable tables, listings, and figures
  • Act as a liaison between the Company, partners, consultants, and vendors
  • Develop and actively manage project plans, schedule and budget to meet deliverables
  • Establish project goals within broad outlines provided by top management
  • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
  • Organizational expert within the CMC subject area
  • Excellent written/oral communication and strong time and project management skills
  • Ability to attend regular team meetings

 

REQUIREMENTS

  • BS + in biology or chemistry, or related field, with industry experience within regulatory affairs, laboratory sciences, quality assurance/control
  • Knowledge of GMP, ICH guidelines, and applicable regulatory requirements
  • 3+ years of pharmaceutical CMC experience

 

PHYSICAL DEMANDS

Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with hands and arms.  Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for entire work shifts. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Physically able to use and operate equipment used in clinical research and trials. Ability to lift, tug, and pull up to 50 lbs.

 

WORK ENVIRONMENT

This job operates in a professional office environment.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

 

APPLICATION INSTRUCTIONS

Please submit a resume and cover letter to jobs@curevovaccine.com  with the position title in the subject title. Alternatively, you may attach a combined PDF of your documents in the fill-in space at the bottom of our website careers page.

 

Curevo Vaccine is a proud Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

A cover letter is required with all applications. An application without a cover letter will not be considered.

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