Join Impel

Impel NeuroPharma is a late stage pharmaceutical company based in Seattle, WA. We are committed to developing the next generation of central nervous system (CNS) drug treatments. Impel’s proprietary Precision Olfactory Delivery (POD™) technology enables many categories of therapeutics to be delivered to the CNS using consistent and predictable upper nasal drug delivery. We are working hard to create life-changing, innovative therapies for CNS diseases and we hope you’ll join us.

Clinical Trial Manager

ACCOUNTABILITY OBJECTIVE: 

This position will be responsible for implementation and oversight of combination pharmaceutical and device clinical studies. The Clinical Trial Manager (CTM) ensures the safe, efficient and timely execution of clinical studies throughout the clinical trial management process. The scope of this position requires excellent organizational, communication, and leadership skills, with significant experience in executing all phases of clinical trials. It also requires the ability to effectively identify and manage vendor personnel while building effective working relationships within the company, clinical study sites, and vendors.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

  • Drives all aspects of clinical trial management and process from initiation, planning, execution, control and closure
  • Acts as the operational focal point and coordinates the clinical trial efforts within Impel and through vendors
  • Responsible for the project scope, timeline, budget, quality, communication, risk and procurement for clinical studies as assigned
  • Assists with protocol development
  • Assists with development of Standard Operating Procedures, guidelines and policies
  • Manages and coordinates vendors involved in the clinical trial
  • Monitors and Controls the execution of the clinical study
  • Responsible for study metrics
  • Review and/or create study documents and tools for the execution of the study
  • Ensure adequate clinical staff training and compliance
  • Collaborates with other relevant groups to identify qualified clinical study sites, and vendors required in the execution of planned clinical studies
  • Oversees qualification, monitoring, and management of clinical study sites

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s Degree in Scientific/Health related field or equivalent years of experience
  • 5+ years Clinical Research/Development experience required, including relevant Clinical Trial Management experience
  • Experience with project, vendor and contract management
  • Knowledge of Good Clinical Practice (GCP) and FDA regulations is expected. Experience with Institutional Review Board (IRB) preparations and submission preferred
  • Experience writing, reviewing and editing clinical protocols and study reports
  • Ability to exercise judgment and determine appropriate action
  • Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, KOLs, and customers.
  • Ability to work independently and manage deadlines
  • Approximately 10% travel. International travel required

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level. Limited travel may be required.

Senior Clinical Trial Manager

ACCOUNTABILITY OBJECTIVE:

This position will assist the VP, CDO in implementation and oversight of combination pharmaceutical and device clinical studies. The Senior Clinical Trial Manager (Sr. CTM) ensures the safe, efficient and timely execution of clinical studies throughout the clinical trial management process. The scope of this position requires excellent organizational, communication, and leadership skills, with significant experience in executing all phases of clinical trials. It also requires the ability to effectively identify and manage vendor personnel while building effective working relationships within the company, clinical study sites, and vendors.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

  • Drives all aspects of clinical trial management and sponsor oversight activities and process from initiation, planning, execution, control and closure
  • Acts as the operational focal point and coordinates the clinical trial efforts within Impel and through vendors and individual consultants- provides robust vendor management
  • Identifies appropriate (CRO) vendors for bidding on Impel Clinical projects
  • In parallel, establishes and leads generation of Clinical Risk Management Plan for study/studies for offering out for bidding
  • Prepares CDO vendor RFPs and manages review of proposal and vendor selection activities
  • Responsible for the project scope, timeline, budget, quality, communication, and risk management for clinical studies as assigned
  • Provides input for annual budget and resource planning
  • Leads clinical study protocol development
  • Assists with development of Standard Operating Procedures, guidelines and policies
  • Monitors and Controls the execution of the clinical studies
  • Responsible for providing study metrics to the leadership team
  • Review and/or create study documents and tools for the execution of the study
  • Ensure adequate clinical staff training and compliance
  • Collaborates with other relevant groups to identify qualified clinical study sites, and vendors required in the execution of planned clinical studies
  • Providing training and/or oversight of more junior Clinical Development and Operations team members

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s Degree in Scientific/Health related field. Advanced degree preferred
  • 10+ years Clinical Research/Development experience required, including relevant Clinical Trial Management experience
  • Strong Experience with project, vendor and contract management
  • Knowledge of Good Clinical Practice (GCP) and FDA regulations including experience with E6(R2) implementation is expected. EMA/EU and TGA knowledge preferred.
  • Experience with Institutional Review Board (IRB)/EC preparations and submission preferred
  • Experience working with external KOL advisers, SABs and DSMBs preferred
  • Strong experience writing, reviewing and editing clinical protocols and associated plans and study reports
  • Experience with (e)TMF management and audit reconciliation and archiving is preferred
  • Experience with critical review of Tables, Listings, and Figures (TLFs)
  • Ability and experience exercising judgment to determine appropriate action
  • Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, and KOLs
  • Ability to work independently and manage deadlines
  • Approximately 10% travel. International travel required

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level. Limited travel (approximately 10%) may be required.

Senior Clinical Data Manager

ACCOUNTABILITY OBJECTIVE:

Reporting to the VP Clinical Development, the Senior Clinical Data Manager is responsible for managing the clinical trial data for multiple assigned projects.  The successful incumbent will act as liaison between Impel and CRO personnel to implement and maintain clinical databases, and ensure data integrity and conformance with current standards.  S/he will collaborate on project or software-related training, and coordinate internal planning and activities such as medical coding, electronic data transfer, and all other aspects of data cleaning.  This individual will provide project oversight of daily, weekly and monthly data management tasks and CRO deliverables to ensure assigned projects and deliverables are on track, delegating tasks (as needed) to other team members.  Additionally, s/he will serve as a technical resource to colleagues, troubleshooting technical problems and ultimately managing more complex projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

  • Act as Lead Data Manager on Impel clinical studies
  • Design, or oversee the CRO’s design of, an Electronic Data Capture (EDC)/Data Management system, including the design/review of Case Report Forms and system edit checks
  • Develop User Acceptance Testing (UAT) Plans and coordinate with team members to perform UAT
  • Develop and/or review Data Management Plans (DMPs), outlining and confirming all data management responsibilities
  • Oversee the completion of data entry, including tracking CRF data entry, query generation/resolution
  • Work with the study team, e.g., Clinical Development, Biostatistics, Regulatory, and/or CRO, to complete comprehensive, timely data review and resolve data issues
  • May develop ad hoc listings, patient profiles, and/or additional data checks using software such as SAS, J-review, or other software
  • May perform coding of medical events/medications
  • Conduct/oversee database lock activities: ensure all database lock activities are performed prior to final database lock, oversee generation of CRF archival files, ensure project documentation is provided to Impel and filed, if applicable
  • Review and/or conduct and document project-specific training for all team members prior to project start and throughout the course of the project, as needed
  • Train or coordinate training for end users on the applicable EDC/ Data Management system, maintaining current system access and ensuring all training records are up to date. May perform study specific CRF training at Investigator Meetings
  • Coordinate and delegate work performed by study data managers, as needed; assist in mentoring of more junior data managers
  • Lead writing/reviewing/updating Data Management related Standard Operating Procedures (SOPs) and oversee training of appropriate staff in their interpretation and use
  • May prepare and present data management topics to Clinical Development and other Impel departments
  • Lead assessment and selection of data management systems, if applicable

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED:

  • Bachelor’s degree in a related field of study preferred
  • 10+ years leading DBM study activities or equivalent combination of education and experience
  • Certified Clinical Data Manager (CCDM) is an asset
  • SAS programming is an asset
  • Minimum 5 years’ experience with Medidata Rave. Experience with other platforms (e.g. Oracle Inform) beneficial
  • Experience working within a Sponsor environment, overseeing vendor and contract management
  • Experience writing, reviewing and editing EDC specifications to assure alignment with clinical protocols and SAPs
  • Knowledge of Good Clinical Practice (GCP) and FDA regulations is expected
  • Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook
  • Strong attention to detail and ability to effectively prioritize tasks and assignments to meet deadlines
  • Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, executive management, external vendors, KOLs, and customers
  • Ability to exercise judgment and determine appropriate action
  • Ability to work independently and unsupervised and manage deadlines

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Must have demonstrated ability to multitask in high pressure, changing conditions.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level.  Limited travel, mostly national, may be required.

Product Development Engineer

ACCOUNTABILITY OBJECTIVE:

Impel’s product development team is a technical, driven, highly collaborative group focused on introducing the best products possible into the market. As an engineer within this group, you will contribute to the development process by focusing on engineering project management, supplier development, and process validation to effectively translate designs into products.

The product development engineer is responsible for developing project plans, monitoring and mitigating risks, and reporting functional execution to keep projects on schedule and address issues and bottlenecks before they become problems. Excellent communication skills are required as the role will provide a conduit between the internal and external development resources.

The ideal candidate has a positive attitude, shows perseverance in problem solving, and is passionate about developing new medical therapies.  You must be a self-starter and be willing to roll up your sleeves to find a solution to any problem.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.

  • With technical staff input, develop comprehensive project plans to be shared with staff and suppliers
  • Own functional management and tracking of development activities at external, global, contract manufacturing organizations and component suppliers
  • Interface with internal cross functional team to ensure all requirements are correctly translated to supplier
  • Outstanding communications skills, keeping both the engineering function and cross functional team up to speed on progress and challenges. The ability to generate quality reports/design documentation is essential
  • Develop and improve departmental project management tools and approaches
  • Participate in the development of process validation at assembly CMOs and component suppliers
  • Meet budgetary objectives and make adjustments to project constraints based on financial analysis
  • Ability to collaborate within a team environment as well as execute independently on project tasks
  • Support design verification testing as required
  • Support product manufacturing through the transfer to operations
  • Must be capable of continuous learning and have a desire to take on an ever-changing list of tasks.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s degree is required in mechanical engineering or similar field – mechanical aptitude required
  • Minimum 5 years of experience as a member of a product development team
  • Track record of successfully developing supplier capabilities
  • Experience in medical device or pharmaceutical industry
  • Experience validating manufacturing processes
  • Multi-task and drive multiple projects forward in parallel
  • Must be proficient in Microsoft Office products
  • Outstanding communication skills
  • Positive team player, willing to step in and fill identified project team gaps

PREFERRED SKILLS

  • Previous experience with contract manufacturing
  • Previous experience commercializing new products
  • Management experience
  • Supply chain management
  • Project management professional certification
  • Injection molding experience
  • Design verification testing experience

PHYSICAL DEMANDS

Must be capable of lifting packages under 50 lbs.  Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level.

TRAVEL

Up to 30% travel is anticipated.

Research Associate II

ACCOUNTABILITY OBJECTIVE:

The Research Associate II will provide analytical chemistry support in Impel’s Analytical & Translational Sciences group. Impel’s product development team is a technical, driven and highly-collaborative group focused on introducing the best products possible into the market. As a Research Associate II, this team member will contribute to product development through the development of methods for analytical testing of drug-device combination products and by carrying out routine stability testing on Impel’s products in development.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.

  • Hands-on laboratory bench work and sample testing supporting development of pharmaceutical products. This includes but not limited to performing HPLC assay and related substances testing, dose and spray content uniformity, device performance testing, particle size distribution and other tests to characterize and demonstrate product performance.
  • Conduct laboratory testing with high degree of accuracy and precision including but not limited to quantitative weighing and dilution, sample handling and processing, instrumental analysis using HPLC, UV-visible spectrophotometry, loss on drying, Karl Fischer, DSC, particle size distribution, and other analytical techniques as required.
  • Conduct and troubleshoot analytical methods for testing raw materials and products.
  • Follow protocols and methods for the transfer and/or qualification/validation of analytical methods as necessary for development of pharmaceutical products. Implement the method qualification/validation. Summarize the results in the lab notebook and reports.
  • Maintain a laboratory notebook in high fidelity.
  • Contribute to lab maintenance/housekeeping, documentation, and training tasks as necessary.
  • Other general laboratory tasks as assigned.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s degree in Chemistry or related field with 2+ years of industry laboratory experience and hands-on experience conducting experiments with HPLC of small molecules
  • Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems
  • Knowledge of working in a GLP and GMP environment
  • Execution of daily activities with extreme attention to detail and ownership
  • Outstanding organizational skills, ability to manage and complete tasks on time
  • Proven ability to adapt and respond to the needs of a growing organization conducting R&D activities; communication and interpersonal skills are emphasized
  • Familiarity with Microsoft Office Suite and Internet based office applications
  • Ability to understand complex instructions and carry out procedures complying with instructions
  • Ability to record and tabulate data; meticulous record keeping in the laboratory notebook

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • This position will require periods of standing in a fast-paced laboratory area to assist in the completion of testing and maintenance. Periods will range from 15 min to several hours standing to fulfill tasks.
  • Must be able to lift 40 lbs. Received shipments of solvents and pharmaceutical products in development will require storage and careful moving in the laboratory to avoid spills.
  • The technician must be able to lift 4L bottles of solvent to pour from one vessel to another to prepare solutions. Spills are to be avoided to protect the safety of the technician and the laboratory staff.
  • May be responsible to move items to assess inventory in busy laboratory area for potentially prolonged periods of time.
  • Ability to use computer, telephone, and other office machines.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Carts and lifts are available to help as needed.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level.

TRAVEL

Up to 10% travel is anticipated.

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