Join Impel

Impel NeuroPharma is a clinical 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, including biologics, to be delivered to the CNS using consistent and predictable intranasal drug delivery devices. We are working hard to create life-changing, innovative therapies for CNS diseases and we hope you’ll join us.

Senior Administrative Assistant

This position will provide outstanding customer service and administrative function to the Engineering, Operations, Clinical and Life Sciences Teams.  The ideal candidate must have a positive attitude, extreme flexibility, excellent organizational skills, ability to deal with ever-changing priorities, and enjoy learning new ways to support faster team execution and capability.

Though reporting to the SVP of Engineering, this position will have a dotted line relationship to the Heads of Clinical and Life Sciences.

ESSENTIAL DUTIES AND RESPONSIBILITIES includes the following. All duties and responsibilities apply in support of Engineering, Operations, Clinical and Life Sciences departments. Other duties may be assigned.

  • Management and planning support: calendars, meetings, department organization, travel and expense reports
  • Coordination of purchasing and receipt activities
  • Administrative support to the Heads of Engineering/Operations, Clinical and Life Sciences, and others, as assigned
  • Partner with other Administrative functions within Impel to manage shipments, deliveries in addition to providing overall company support as necessary
  • Departmental budget tracking for expenses and purchases
  • General departmental organization on Dropbox
  • Management of visitors
  • Other duties as assigned

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • High School Diploma. Bachelor’s degree is highly desired
  • 5 plus years of experience as an Administrative Assistant in a fast-paced, progressive environment
  • Life Sciences/Biotech experience is highly desired
  • Must be proficient in Microsoft Office and Visio. Proficiency with Microsoft Project or Smartsheet is a plus.
  • Must be capable of continuous learning and have a desire to take on an ever-changing list of tasks.
Senior Director Operations/Supply Chain

As the Senior Director, Operations/Supply Chain you will direct and manage the global supply of clinical and commercial products to achieve business objectives.  You are accountable for the execution and effectiveness of the clinical and commercial demand planning and S&OP process.  You will operate at the highest levels of decision making related to combination product supply.  The ideal hands-on candidate is detail oriented, timeline driven, has a positive attitude, is flexible, organized, multi-tasks, can deal with ever changing priorities.

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

  • Lead the collective supply for all Impel clinical and commercial products including
    • Clinical demand planning and supply for global studies
    • Commercial forecasting, demand planning and management of commercial drug and device supplies
    • Management of the commercial supply chain, including device component suppliers and assemblers, drug manufacturers, co-packaging suppliers, and serialization and distribution of product.
  • Develops departmental structure, function, and personnel to deliver upon necessary departmental and company Key Performance Indicators.
  • Accountable for the S&OP process and the commercial supply chain.
  • Drive and maintain senior level engagement in the S&OP process, directing, driving and facilitating decision for this process across all Impel programs.
  • Assess and communicate risk and opportunity related to the global supply of clinical and commercial product.
  • Oversee global logistics, product packaging for shipment, and material movements
  • Participate on product development teams to ensure supplies are provided in time to achieve key performance indicators.
  • Interacts and aligns department function with Impel’s New Product Introduction teams.
  • Establishes processes to efficiently manage material control within Impel and at suppliers
  • Develops and manages annual departmental budgets for inventory, materials, and logistics within the Operations/Supply Chain function.
  • Oversee import/export brokerage relationships and process
  • Establish and oversee third party logistics firm(s) for distribution and fulfillment of Impel’s commercial products.
  • Works with Quality Assurance to ensure Supplier Quality requirements are achieved and maintained.
  • Develops and publishes metrics to communicate and manage the effectiveness of the Operations function and the global supply chain leading to increased efficiency, cost reduction and improved customer service.
  • Identifies areas for improved efficiency and drives cost reduction for commercial programs through appropriate means.
  • Interacts with Finance to ensure alignment of product costing within the ERP system.
  • Assists in developing logistics relationships, plans and procedures.
  • Travel up to 30% is anticipated.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s degree in Business, Finance, Logistics or Engineering is required. Minimum 10 years of related Operations and Supply Chain experience in a fast paced, progressive biotech, medical device or other regulated environment is required.
  • Must be proficient in Microsoft Office and Visio.
  • In-depth, direct experience with the implementation and use of commercially available ERP systems is required. Deep knowledge of demand planning and the S&OP process is required.
  • Understanding of the end to end Supply Chain and independencies across all corporate functions is required.
  • Experience in medical device, pharmaceutical or biotech company is required
  • Experience in the successful management of supply for both clinical and commercial supply of pharmaceuticals, medical devices or combination products is required.
  • Ability to develop, coach and guide a leadership team in the execution, development of strategies leading to the achievement of company Key Performance Indicators is required.
  • Proven experience in developing and nurturing relationships with critical manufacturing partner is required.
  • The ability to collaborate across all levels of the organization and Supply Chain is required.
  • Demonstrated experience with best practices related to Operations and Supply Chain for commercial products is required.

EDUCATION, EXPERIENCE AND/OR SKILLS PREFERRED

  • Direct knowledge of import/export regulation as it pertains to FDA regulated products is highly preferred
  • An advanced technical degree or MBA is preferred.
  • Proficiency with Microsoft Project or Smartsheet is preferred.
Clinical Process and Compliance Manager

This position will assist with ongoing GCP compliance activities within Clinical Operations and by Impel’s clinical trial management teams and ensure adherence to applicable CGP regulations and guidance. Assist with identification, qualification, selection, and implementation of electronic systems, e.g. EDMS. Assists with the development, implementation, maintenance and training associated with Clinical Operations SOPs and other work process guidance. Assists with the development of clinical trial quality management plans and processes. Assists with the preparation and support for Regulatory Authority GCP inspections. Collaborates with and supports Impel’s Clinical Quality Assurance group as necessary.

Responsibilities include the following. Other duties may be assigned.

  • Contributor to the Impel NeuroPharma Clinical Quality Management System
  • Proficient in risk management principals
  • Collaborates with Impel Clinical Quality Assurance in the preparation and support of Regulatory Authority GCP inspections
  • Assists Clinical Operations staff with interpretation and application of global GCP regulations
  • Assists with clinical trial GCP training of Impel staff
  • Performs Clinical Quality Management compliance assessments/investigations
  • Assists with the development of new SOPs and associated documents as well as the monitoring,  identification, and addressing any gaps
  • Assists Clinical Operations in formulating responses to quality observations/findings

Qualifications

  • Bachelor’s Degree required
  • 5 years’ minimum experience in the pharmaceutical/biotech industry or relevant clinical research organization experience, including clinical auditing &/or monitoring &/or trial management experience
  • Significant knowledge of global clinical trial regulations and guidelines
  • Experience in supporting clinical trial GCP compliance and clinical quality management activities
  • Experience in supporting Regulatory Authority GCP inspections
  • Experience working in a rapidly growing company while quality and compliance systems are being established (preferred)
  • Previous experience conducting or supporting clinical site and/or vendor audits (preferred), development of CAPAs and monitoring their implementation to successful resolution
  • Excellent interpersonal and communication skills (both written and oral)
  • Ability to problem solve and delegate appropriate tasks
  • Ability to work independently and manage deadlines
  • Strong leadership skills, self-motivated, calm under pressure and adaptable to a dynamic environment
  • Proficiency in MS Word, Excel and PowerPoint
Clinical Trial Manager

This (in-house) 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.

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

Qualifications

  • 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
Clinical Trial Associate

This (in-house) position will provide support for all clinical activities, ensuring the successful planning, execution and completion of clinical trials as well as support for setting up and smooth running of a clinical operations department.

Responsibilities include the following. Other duties may be assigned.

  • Support the Clinical Project and Program managers in planning, setting up and executing assigned clinical trial(s)
  • May act as central contact for the clinical team for designated project communication, correspondence and associated documentation
  • Create and maintain trackers that monitor department and project compliance and performance
  • Maintain databases for appropriate study administration
  • Assist with development and editing of study related materials
  • Prepare, handle and distribute Clinical Trial supplies and maintenance of tracking information
  • Participate in team meetings and generate meeting agendas and minutes and monitor action item completion
  • Participate in investigator and vendor meetings as needed
  • Prepare and perform review of the TMF including all GCP-related documents
  • Administer study and related documents, curating paper and/or electronic records as required before and during the study
  • Provide or facilitate training related to clinical trial documentation
  • Coordinate with external vendors & sites
  • Review and update SOPs as needed
  • Generated/Track Check Requests for Vendor Payments and Pass Thru Payments based on the request received by PM and/or Clinical Operations Manager
  • Tracking of invoices and routing contracts for purchase orders
  • Tracking and filing clinical documents as needed
  • Participate in special development and validation of new electronic systems

Qualifications

  • Bachelor’s Degree in a science, health, or related field or equivalent years of experience
  • 1-3 years relevant experience in pharmaceutical industry or CRO
  • Experience supporting clinical trials
  • Basic knowledge of drug development, FDA, and GCP regulatory guidelines is a plus
  • Excellent oral and written communication
  • Excellent organizational and problem solving skills
  • Proven ability to learn and adapt in an evolving work environment
  • Proficiency with MS Word, Excel, PowerPoint and Adobe Acrobat
Director of Marketing

The Director of Marketing will be the first full time marketing hire at Impel and will initially have broad responsibility for commercial development of Impel’s pipeline of products. This includes the development and implementation of Impel’s commercial strategies for existing drug-device candidates including: market landscape and assessment (using primary and secondary data sources), TPP development, marketing and market research plan (pre-commercialization and launch), branding and messaging. It may also include assessing the commercial value of future drug-device candidates as opportunities arise. As the company quickly grows and changes with emerging clinical data over the next year, the role will evolve and may become more focused based on the needs of the company and interests of the Director.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Develop and execute brand strategies and brand plans including market assessment, competitive landscape review, TPP development, product positioning, promotional messaging, and multichannel marketing.
• Plans, directs, and executes all marketing strategies, functions, policies, objectives and initiatives.
• Maintain clear vision of product marketplace, focusing on new product potential, competitive developments, shift in treatment paradigm and opportunities.
• Responsible for reimbursement, access and pricing strategies and development of pricing models by segment.
• Develop appropriate marketing and advertising support (pre-commercialization and launch) for product markets including marketing communication materials, tradeshows, website, etc.
• Work with Business Development (BD) to provide input during due diligence activities that include market and competitive insights, forecasting and ROI.
• Plan and develop company marketing and communications materials. To include print media, video, webinars and other training media.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
• Bachelor’s degree in Marketing, Business or life sciences required. MBA is preferred.
• 7-10 years of marketing and commercial experience in the pharmaceutical/medical device/life sciences industry.
• Experience with marketed and pipeline products, high growth companies, neuroscience and/or drug/device combinations ideal.
• Strong analytical skills and a working knowledge of business finance, pricing and forecasting.
• Deep understanding of the pharmaceutical value chain and drivers in the pharmaceutical business (Payors, Physician and Patient).
• Demonstrated high level of integrity and business ethics.
• Excellent verbal and written communication skills.
• Ability to manage multiple conflicting priorities.
• Travel expectation: 20-40%.

Sr. Specialist/Manager, Regulatory Operations

This position will be responsible for managing and executing moderately complex submission, compilation and publishing activities associated with electronic submissions and for providing subject matter expertise in eCTD implementation. The position (title) offered will be dependent on the level of experience.

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

  • Prepare and/or oversee the preparation of high-quality regulatory submissions for multiple programs/products in development (e.g. IND, CTA, NDA, BLA) with a focus on eCTD.
  • Manage the review of regulatory submission documents for completeness and quality in accordance with regulatory agency requirements and standards
  • Manage projects with vendors and contractors to meet schedules and ensure quality
  • Serve as the Regulatory Operations lead, collaborating with Regulatory Affairs and the cross-functional project team to develop and implement submission strategies and timelines.
  • Provide functional and technical guidance with respect to submission of clinical trial applications and marketing applications
  • Manage and maintain regulatory information including relevant logs, trackers and archives of regulatory submissions, correspondence and commitments.
  • Manage and maintain regulatory document templates and regulatory style guide
  • Develop applicable SOPs and/or other written practices relating to the regulatory affairs operations function
  • Develop and provide training on the use of regulatory templates (i.e. StartingPoint), processes and tools critical to compiling electronic submissions (i.e., software, authoring templates and publishing tools)
  • Advise and direct evaluation, selection, and implementation of technology and equipment related to submission planning, preparation, assembly, dispatch and/or archiving
  • Assist in and/or lead the promotion of electronic initiatives in the company in support of with electronic submissions

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s Degree or higher in a relevant field
  • 5+ years of direct, hands-on experience with regulatory submission and project coordination
  • 5+ years of experience with processes and standards, regulatory technology (including publishing software) and document management is required.
  • Good knowledge of drug development, FDA, and eCTD regulatory guidelines with Working knowledge/understanding of biologics and/or small molecule product development, including CMC, pre-clinical, and/or clinical development
  • Excellent oral and written communication, with particular attention to detail
  • Excellent organizational and problem-solving skills
  • Proven ability to learn and adapt in an evolving work environment
  • Advanced-level proficiency with MS Word, Excel, and Adobe Acrobat
  • Competency in MS Project, MS Visio applications and XML and SQL specifications is preferred

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