Join Our Team

Become a part of Edgewise

Edgewise is a small, diverse team with critical work to do. We seek to hire collaborative and motivated individuals who share our vision for developing innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need.  Edgewise provides excellent compensation and benefits, as well as the opportunity to be part of a passionate and driven biotech team in beautiful Boulder, CO. With numerous bike paths and sunny days, many employees enjoy commuting to work by bike, and spending the weekends exploring the Rocky Mountains. It is easy to understand why Boulder has won many awards and accolades for its recreation, health, culture and overall quality of life.

Edgewise is proud to be an equal opportunity employer.

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 clinical study manager to join our passionate and driven team. The Senior Clinical Study Manager will oversee the activities required to execute, conduct and complete multiple studies within established timelines and budgets.

Primary Responsibilities:

  • Propose, select and manage clinical operation vendors. Ensure adherence to scope of work, budget and study deliverables. This includes preparing formal Request for Proposal (RFP), identifying qualified vendors, coordinating distribution of RFPs, triaging bids and recommending selection of finalist.
  • Select investigational sites to ensure adherence to scope of work, budget and study deliverables.
  • Function as primary liaison for site personnel and internal company personnel regarding study-related topics and/or questions.
  • Negotiate site study budgets and contracts with internal teams, vendors, and sites.
  • Organize and lead cross-functional clinical (e.g., data management, safety surveillance, biostatistics) and interdisciplinary teams (e.g., pre-clinical, manufacturing, regulatory, quality assurance, project management, legal, finance).
  • Coordinate the preparation of clinical program documents (study proposals, study protocols, Clinical Study Reports and submissions).
  • Develop, implement, and ensure adherence to the monitoring plan for assigned studies.
  • Organize Investigator Meetings and any other internal/external meetings related to assigned clinical trials and deliver presentations at these meetings.
  • Ensure the collection, accuracy, and storage of study-related documents.
  • Facilitate study monitoring activities for assigned studies and personally conduct site visits as needed.
  • Ensure the review and tracking of monitoring reports for content, quality, timeliness, and GCP adherence.
  • Identify obstacles and related solutions and implement approved plans in collaboration with the study team to ensure study objectives, scope, and timelines are being met.
  • Track, measure, and report the status of project milestones.
  • Assist in the development and implementation of clinical Standard Operating Procedures and associated tools.
  • Disseminate clinical study communications to all functional groups
  • Participate in the selection and management of CROs and other vendors
  • Interact with clinical research investigators and sites
  • Assist Regulatory with the preparation of regulatory submission packages according to local regulations
  • Assist the Clinical Team with CRF design and generation of protocols, protocol amendments, informed consent forms and investigator brochures
  • Participate in strategic planning meetings
  • Report on progress of milestones and inform of escalating issues that need intervention
  • Conduct regular team meetings, assigning action items and due dates, as applicable.
  • Work across internal departments to maintain credibility, trust, and support of employees and other stakeholders
  • Organize, attend, present and provide training at investigator meetings
  • Oversight of CRAs/monitors
  • Provides guidance to CTA/Sr. CTA
  • Primary clinical study contact both inside and outside the organization.

Skills & Experience:

  • B.S./B.A. in nursing, scientific or business-related field
  • 7+ years of clinical operations experience in neuromuscular and/or rare disease clinical trial design and conduct
  • Experience in Duchenne Muscular Dystrophy, rare disease, pediatric studies or related is preferred. Experience with RWE or Natural History Studies is a plus also.
  • In-depth knowledge of clinical research operations, including GCP, FDA regulations, and ICH guidelines
  • Proficiency in Electronic Data Capture and Clinical Trial Management Systems
  • Solid understanding of the processes and interactions essential for successful program management
  • Knowledge and understanding of clinical trial management including study start, conduct and reporting
  • Working knowledge of the data management processes and principles
  • Experience and discipline in document maintenance and management
  • In depth knowledge of ICH/GCP guidelines, basic regulatory requirements and clinical trial operations
  • Understanding of therapeutic area/study rationale
  • Understand how to develop and manage study budgets and timelines
  • Strong project management and organization skills
  • Strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization
  • Solid experience working on a successful clinical operations team
  • Demonstrated leadership potential
  • Eager to be part of an organization discovering and developing drugs for patients with severe illnesses to live longer, better lives

Compensation: $160,000 – $225,000 (depending on level/experience)

About the Position

Edgewise is seeking an experienced biotech/pharma clinical operations leader to join our passionate and driven team. The Associate Director, Clinical Operations will be responsible for leading multiple programs or a small franchise for clinical operations.

Primary Responsibilities:

  • Lead the development of operational strategy in collaboration with key operational stakeholders
  • Implement and mitigate resourcing strategies to deliver best efficiency and value
  • May lead therapy area clinical operations meeting
  • Lead critical business initiatives to support best practice across clinical operations
  • Lead the development of critical process standards, policies and SOPs
  • Manage overall clinical trial budget for all assigned programs or franchise
  • Ensures that projects continue to meet expectations and make business sense
  • Provide leadership, guidance and direction to assigned staff
  • Implement performance standards and is responsible for performance management
  • Proactively serve on Clinical Operations Leadership Team
  • Responsible for managing multiple operational excellence teams to drive best practice across Clinical Operations and development within a matrix organization
  • Develop and maintain effective working relationships with external partners

Skills and Experience:

  • B.S./B.A. in nursing, scientific or business-related field
  • 10+ years of clinical operations experience in neuromuscular and/or rare disease clinical trial design and conduct
  • Experience in Duchenne Muscular Dystrophy, rare disease, pediatric studies or related is preferred. Experience with RWE or Natural History Studies is a plus also.
  • In-depth knowledge of clinical research operations, including GCP, FDA regulations, and ICH guidelines
  • Proficiency in Electronic Data Capture and Clinical Trial Management Systems
  • Significant experience with project management – including budget management, timeline management, and hands-on study management experience.
  • Medical writing experience is a plus.
  • A strong communicator with excellent verbal and written communication skills
  • A highly collaborative person who is able to respond to constantly changing circumstances and needs
  • Strong leadership skills
  • Demonstrated ability to develop operational strategy for a program(s) and the associated studies, including development of timelines, communication plans, risk management/ contingency plans and budgets at the program and study level
  • Strong understanding of R&D and the drug development process
  • Advanced understanding of clinical operations and ability to influence clinical protocol designs
  • Advanced understanding of performance metrics data and how to implement and utilize to drive operational performance
  • Understands the role of the study and program team and can drive operational value through assigned staff in both areas
  • Able to interpret the impact of the regulatory environment and anticipate changes to deliver operational goals
  • Successful track record of delivering programs on schedule and within budget
  • 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

About the Position

Edgewise is seeking an experienced biotech/pharma senior clinical trials associate to join our passionate and driven team. The Senior Clinical Trials Associate will provide logistical support for study teams, including development, maintenance, and management of appropriate study documentation.

Primary Responsibilities:

  • Collect, review, and approve regulatory documents from clinical sites
  • Initiate, maintain, and reconcile Trial Master File
  • Set up and maintain tracking systems and tools to report study metrics to support the clinical study
  • Coordinate communication of tracking information within study teams and to clinical sites
  • Collaborate with project manager to assure timely communication and tracking of critical clinical events and milestones
  • Manage monitoring reports and follow up within project-specific timelines
  • Manage and track clinical and non-clinical supplies
  • Manage and track study-specific payments
  • Coordinate investigator meeting planning in concert with travel planners, including preparing meeting materials and on-site meeting implementation
  • Assist with oversight of CRO, including project tracking of subject and site information, preparing metrics and updates for management
  • Participate in the development, review, and implementation of departmental SOPs and processes
  • Review site study documents (including informed consent template and study tools/worksheets), investigator contracts, and site payments
  • Track performance of CRO pre-site selection and site initiation, as well as interim, close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements
  • Improve quality results by studying, evaluating, and re-designing office processes and implementing
  • Assist study teams with study specific documentation
  • Coordinate communication of tracking information within study teams and to clinical sites
  • Work across internal departments to maintain credibility, trust, and support of employees and other stakeholders
  • Ability to accept direction and guidance from more senior colleagues and managers

Skills and Experience:

  • Associate Degree in related field
  • 4+ years clinical trial support experience, or equivalent
  • 2+ years industrial clinical trial support experience, or equivalent
  • Advanced skill level in computer applications including word processing, spreadsheets, database, presentation/graphic software, and Adobe Acrobat
  • Understands the phases and basic documentation for clinical trials
  • Familiar with the roles of the CSM and CRA including site visits
  • Solid project management skills to independently manage projects with assistance from Sr. Clinical Ops staff
  • Demonstrated ability to communicate and coordinate activities at the clinical site level
  • Able to proactively identify project challenges/risks and implement appropriate action with some supervision
  • Understand ICH/GCP guidelines, basic regulatory requirements and clinical trial operations
  • In depth knowledge of MS office
  • Strong oral and written communication
  • Able to prioritize and implement multiple activities
  • Ability to present information clearly and logically
  • Strong attention to detail and organized
  • Solid problem-solving skills
  • Ability to coordinate projects to successfully meet timelines
  • Eager to be part of an organization discovering and developing drugs for patients with severe illnesses to live longer, better lives

Salary range: $50,000 – $80,000

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)