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.

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 Business Development

The Director of Business Development will lead ongoing and new business activities that result in licensing, partnering or acquisition of internal and/or external assets. This position will act as a strategic leader and thought partner to Impel’s leadership team and will drive key business partnerships and opportunities.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
• Drive all aspects of business development efforts, including strategic partner identification, partnering, in-licensing, out-licensing and related contracting activities.
• Develop and manage relationships across a network of potential partners particularly small and large biopharmaceutical companies in the neuroscience industry
• Develop and maintain Impel’s knowledge on the interests of potential partners and competitive activities
• Coordinate evaluation of new opportunities including market and financial analyses.
• Assist in negotiation of terms and formulation of proposed offers for transaction under evaluation.
• Interact on a daily basis with cross-functional stakeholders in support of execution of ongoing transaction/development of final contracts.
• Serve as one of the company’s ambassadors to the market as a representative at industry conferences.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
• Bachelor’s degree with 7-10 years’ experience in biotech/pharma business development.
• Experience in new business development activities, including customer interaction, acquisition and procurement processes, competitive assessment, and strategic planning.
• Excellent analytical skills, including familiarity with financial modeling.
• Outstanding communication skills (interpersonal, verbal and written).
• Strong leadership skills.
• Exceptional project and customer management skills.
• Excellent teamwork and collaboration skills.
• Travel expectation: 30-50%.

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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