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Become a part of Edgewise

Edgewise Therapeutics is a biotechnology company harnessing proven expertise and understanding of skeletal muscle physiology to develop novel, transformative therapies for serious muscle diseases. Based in Boulder, Colorado, we have built a state-of-the-art muscle research facility to capitalize on new insights into the nature and consequences of muscle adaptation and injury with disease. We have recently added a small lab facility in Portland, Oregon. Edgewise recently completed an IPO which will support the advancement of Edgewise Therapeutic’s lead product candidate into clinical development for Duchenne and Becker Muscular Dystrophy (DMD and BMD) as well as expansion of the company’s pipeline. The company’s leadership team has founded multiple biotechnology startups, several of which have gone on to become publicly-traded companies and brings to bear a depth of experience in drug discovery, development and commercialization.

We offer an excellent compensation package including competitive base salary, discretionary bonus, company ownership and comprehensive benefits. Edgewise also offers the opportunity to be part of a small, collaborative and passionate biotech team

Edgewise is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.

If you are interested in an open position, please select the position below and upload your resume. We look forward to hearing from you.

Recruiters: Edgewise does not accept resumes from recruitment agencies for our position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

Current Openings

About the Position

Edgewise is seeking an experienced biotech/pharma quality assurance leader. The Associate Director, QA will build and maintain a quality system compliant with applicable GxP requirements.

Primary Responsibilities:

  • Plan and perform domestic and international audits/inspections ensuring compliance with the FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards
  • Prepare clear and concise written reports of audit observations including an assessment of compliance; adequacy of action plan; recommendations for corrective action; follow up activities as needed to monitor corrective action; and tracking corrective action commitments through closure
  • Review investigations conducted by third parties and provide input into CAPAs; track investigations to ensure resolution and closure
  • Track change control documents received from third parties that require company review and approval
  • Review and approve batch manufacturing records, deviations, CAPAs, specifications, change controls, and test methods to ensure compliance with cGMP requirements
  • Disposition of GMP lots of API and drug product
  • Provide oversight of stability programs to ensure sufficient data to support use of clinical products
  • Retain and archive quality system records
  • Manage training requirements to ensure all applicable personnel have the appropriate training and experience to perform their job function and their qualifications are adequately documented
  • Generate, approve, and maintain SOPs
  • Oversee documentation, reporting, and closure of all compliance issues
  • Develop detailed understanding of regulatory guidelines and provide recommendations to team members, as needed
  • Provide Quality input to the development of regulatory strategies
  • Improve quality results by studying, evaluating, and re-designing processes and implementing changes
  • Manage third parties contracted to perform functions in support of GxP activities
  • Interface directly with vendors in the negotiation of quality agreements and the management of quality-related issues
  • Work closely with employees involved in GxP activities to identify, evaluate, and recommend solutions to issues identified in the performance of GxP audits

Skills and Experience:

  • B.S. in scientifically-related field
  • 8+ years of quality assurance or quality control experience, including planning and performing quality system audits, in a pharmaceutical development organization
  • Extensive knowledge of GxP regulations and SOP implementation
  • Proven ability to build a strong and flexible Quality team
  • Thinks creatively, develops and executes plans within a fast-paced environment
  • Excellent analytical and problem-solving skills, with the proven ability to think strategically
  • Highly effective team and interpersonal skills with the ability to work across numerous scientific disciplines
  • Excellent diplomatic, analytical and communication skills, both verbal and written
  • Eager to be part of an organization discovering and developing drugs for patients with severe illnesses to live longer, better lives

Salary range: $120,000 – $180,000 (depending on level/experience)

About the Position

Edgewise is seeking an experienced biotech/pharma project manager with experience in preclinical and clinical development. The Project Manager will manage cross-functional drug development project teams/sub-teams to ensure appropriate planning and operations are in place to enable completion of assigned projects within scope, on schedule, and within budget constraints.

Primary Responsibilities:

  • Participate on cross-functional teams made up of internal and external members including scientists with expertise in drug discovery, clinical development, pharmacology and operations as well as CMC and regulatory affairs to develop and manage timelines and ensure effective team communication.
  • Aid project teams in framing their project work, prospectively identify risks and opportunities, highlight resource constraints, understand issues, prepare mitigation and contingency plans as well as facilitate resolutions
  • Ensure accurate tracking and reporting of project milestones and deliverables
  • Manage relationships and external resources with vendors/CROs and collaborators
  • Draft meeting agendas and capture key meeting decisions to ensure that timelines and next steps are understood and communicated
  • Identify and communicate key information, timelines, project risks, and resource constraints to senior management via written communications, presentations, and verbal updates
  • Participate in implementing company-wide improvements across functional areas

Skills and Experience:

  • BS, MS or PhD biology or pharmacy, drug discovery development
  • 8+ years experience in pharma/biotech, 5+ years in program management function
  • Prior experience working with scientists to progress from candidate to proof-of-concept, including CMC, clinical operations and regulatory
  • Experience creating and actively managing integrated timelines and budgets across internal and vendor/CRO project teams
  • Understanding of drug discovery and development process
  • Able to simplify complex components into effective communication plan; strong executive presentation and written skills
  • Project Management Professional (PMP) certification a plus
  • Ability to balance multiple tasks in a fast-paced environment
  • Flexible and proactive approach and diplomatic skills
  • High level of integrity and discretion
  • Proficient in Microsoft Office Suite (Outlook, Word, Excel and PowerPoint, Project)
  • Strong computer skills and knowledge of available scientific resource databases and search engines desirable
  • Strong team player with the ability to build relationships across and outside the organization
  • Eager to be part of an organization discovering and developing drugs for patients with severe illnesses to live longer, better lives

Salary range: $120,000 – $180,000 (depending on level/experience)

About the Position

Scientific position with a range of duties including performing high-quality experiments; producing consistent and reliable data; and reporting results in a timely and organized manner. This position will be based in Portland, Oregon.

Essential Duties/Responsibilities:

  • Learn and perform muscle experiments to investigate a specific question or problem in
    collaboration with supervisor and/or project team members
  • Conduct detailed wet laboratory experiments with appropriate technique and adequate
    controls satisfactory to substantiate/replicate results
  • Excellent hand eye coordination required to efficiently screen novel drug compounds
  • Coordinate laboratory work and schedule with the objectives of the team
  • Interpret basic experimental results and draw data driven conclusions
  • Report organized data, making comparisons, identifying trends and unique results
  • Make suggestions to improve laboratory efficiency and expand research capability
  • Operate at a high level of competence in laboratory technology related to the assigned project
  • Demonstrate basic command of scientific techniques and tools used in the research field
  • Participate in project team meetings
  • Maintain clear scientific records electronic form
  • Update job knowledge by participating in educational opportunities; reading professional publications; maintaining professional networks; and participating in professional organizations
  • Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures
  • Perform other duties as assigned by supervisor

Education, Experience and Skills Requirements:

  • B.S. in scientifically-related field
  • 2+ years of research laboratory experience
  • Familiarity with safe and efficient laboratory practices
  • General scientific computer and software application proficiency
  • Bioinformatics knowledge a plus
  • Muscle physiology knowledge a plus

About the Position

Edgewise is seeking an ambitious synthetic medicinal chemist, eager to contribute to the discovery of novel small-molecule drugs. As a Scientist in Medicinal Chemistry you will be responsible for the efficient design and synthesis of novel compounds for ongoing and emerging projects, identification and application of SAR to compound design, and team-driven optimization of clinical candidates. Responsibilities will also include management of CRO-driven collaborations, translation to large scale chemistries of successful candidates, and contribution to patent and publication preparation.

Primary Responsibilities:

  • Utilize synthetic organic chemistry to investigate, identify, develop, and optimize methods
  • Initiate and execute the design, synthesis, purification and characterization of organic small molecules via multi-step synthesis
  • Propose and explore alternative synthetic routes and synthetic strategies, troubleshoot reactions and multistep reaction sequences
  • Generation of new scientific synthetic and medicinal chemistry proposals for lead optimization efforts
  • Contribute ideas for novel small molecules based on SAR, X-Ray crystallography and scientific literature
  • Oversee and effectively manage CRO chemists
  • Maintain close collaborations with fellow chemists and researchers across disciplines in a team environment
  • Maintain a command of relevant scientific literature and incorporate into individual project(s) as well as the overall program
  • Engage in medicinal chemistry discussions, prepare and present research results in chemistry and project team meetings
  • Prepare and deliver scientific presentations and data to colleagues within and outside the company
  • Maintain clear, detailed, and up-to-date records of research using electronic laboratory notebooks

Requirements:

Education, Experience, Skills:

  • Masters, PhD in Organic Chemistry or related field with typically, 8-10+ (MS) or 0-4+ (PhD) years of experience; Postdoctoral or pharmaceutical industry experience desirable
  • Understanding of ADME, physicochemical properties, and principles of medicinal chemistry
  • Demonstrate the ability to resolve key scientific hurdles by effectively utilizing available information and technical expertise
  • Exceptional communication skills; ability to develop, implement and clearly communicate chemistry strategies and progress to team
  • Build strong relationships with peers and cross functionally with partners outside of teams to enable high performance
  • Self-motivated with the ability to work independently and effectively in a team-oriented, multidisciplinary environment
  • Familiarity with safe and efficient laboratory practices
  • General scientific computer and software application proficiency
  • Max. file size: 2 MB.