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 novel, transformative therapies for serious muscle diseases.  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

Position Summary:

Responsible for establishing company’s strategic development roadmap and to provide exemplary scientific input into company’s clinical programs to support the overall corporate strategy; modeling and setting the company’s development culture.

Responsibilities:

  • Direction of clinical development strategy and processes within the company to ensure efficient, high quality therapeutic development programs, based on rigorous scientific, medical, and regulatory standards
  • Provide strategic and operational guidance in the management of the company’s R&D objectives
  • Contribute to the development of the company’s overall infrastructure and growth strategy
  • Create and communicate a compelling vision inside and outside the Company that generates excitement, credibility, and support of the clinic research mission.
  • Specific responsibilities in directing the Development Programs:
    • Accountability and ownership of clinical development plans, clinical concept sheets and protocols, confidential information brochures, data analysis plans, clinical study reports, and clinical sections of regulatory submissions (IND, CTA, and CTD)
    • Oversee the drug safety/pharmacovigilance efforts and prepare the organization for the management of clinical stage assets
    • Medical monitoring of clinical research studies
    • Function as a clinical expert in the evaluation of early stage assets
    • Ongoing interpretation of clinical safety and efficacy results for regulatory and pharmacovigilance purposes
    • Lead the Regulatory team. Assist in developing and reviewing all submissions to regulatory authorities (e.g., Meeting Packages, Pre-Market Approval application, & clinical components of other regulatory correspondence) and represent the company at key meetings
    • Seeking partnerships with academic institutions, with other pharmaceutical companies and Health Authorities
  • Promote and engage in a culture that reflects the company’s values, encourages high performance, and rewards creativity, innovation, and productivity
  • Influence collaborators, consultants, partners, investors, and other key individuals by demonstrating a deep understanding of all aspects of the company’s operations, scientific and clinical endeavors, and business objectives
  • Direction of peer-reviewed abstract and manuscript preparation and presentations
  • Collaborate with potential or current global pharmaceutical partners to ensure products are properly positioned in designated regions
  • Support company and all current and future products with proactive engagement of key influencers (including KOLs, health system administrators, societies, and governmental agencies), in the utilization of company products and the external research and guidelines that affect them
  • Serve as a company spokesperson regarding all clinical/medical matters.  Lead company resources in addressing laboratory, clinical, and patient product-related inquiries
  • Ensure that the organization and its mission, vision, values, and programs are consistently presented in a strong, positive image to relevant stakeholders
  • Personnel management responsibilities:
    • Attract, assess, retain, and develop highly competent, experienced clinical personnel who meet Edgewise’s high standards of team spirit, creativity, and technical depth
    • Setting of clear, focused, challenging targets that allow highly skilled and appropriately empowered clinical professionals to accomplish significant business objectives consistent with departmental goals
    • Create and encourage an environment that stresses open, candid, and timely feedback relative to performance
    • Participate in a fast paced, results-oriented environment where the one’s knowledge and skill will be leveraged company-wide
    • Share medical expertise with counterparts in across functional areas
  • Maintain knowledge of and comply with Good Clinical Practice (GCP) specifications as practiced in different geographies
  • Update job knowledge by participating in educational opportunities; reading professional publications; maintaining professional networks; and participating in professional organizations
  • Continuously develop and maintain a “state of the art” level of knowledge of developments and trends in drug development
  • Perform other responsibilities as requested by the CEO or the Board

Education, Experience, Skills:

  • Board Certified MD/PhD, or MD with medical research and drug development experience and a record of exceptional achievement
  • 10+ years of relevant industry experience in either the pharmaceutical or biotechnology industries to include orphan indications and pediatric populations; specific experience in the area of musculoskeletal, neuromuscular and/or rare diseases is desirable.
  • 10+ years of clinical experience in the life science industry
  • 10+ years of experience leading and influencing individuals and teams and building consensus
  • Demonstrated knowledge of GCP rules and regulations

Position Summary:

Development position with broad range of duties, including selection and supervision of clinical research organizations, central laboratory, and pharmacokinetic analytical laboratory vendors; negotiation of, and ensuring adherence to, clinical and laboratory budgets; coordinating communication with clinical sites and Principal Investigators; coordinating activities between clinical sites, drug supply, and quality assurance activities; data monitoring to ensure high-quality clinical trials; and advancing company goals through actively contributing to clinical development strategy

Responsibilities:

  • Identify and evaluate contractors to successfully execute clinical studies, including but not limited to, negotiating pricing and timelines with CROs, sites and central laboratories
  • Act as the primary contact with CROs, sites and central laboratories for all study related matters including, but not limited to, clinical planning, patient recruitment, compliance with protocols, and monitoring of progress from start-up through final study report writing
  • Drive execution of clinical trial plans to deliver compelling safety, pharmacokinetic, and efficacy data supportive of regulatory and marketing proof-of-relevance
  • Proven ability in clinical planning, patient recruitment, compliance with protocols, and monitoring of progress from start-up through final study report writing
  • Establishing critical timelines and directing the activities of employees, collaborators, clinical sites, and clinical investigators to meet required deadlines and target goals
  • Devise and implement budgets, cost controls, and resource planning to meet corporate objectives
  • Work with contracted data management team on eCRFs for appropriate content, clarity, completeness, and performance in accordance with protocols and data requirements
  • Ensure timely and accurate data capture by vendors, and prompt correction of erroneous entries
  • Critically reviewing and challenging the work of project team members while offering discerning input and solutions
  • Contribute to the recruitment, retention and nurturing of key scientific, regulatory, and clinical personnel
  • Taking a leadership role at development team meetings, including planning, guiding, and directing content/participation
  • Influencing collaborators and consultants by demonstrating a deep understanding of all aspects of the company’s projects, data, results, and objectives
  • Crafting, reviewing, and approving clinical reports and presentations for internal and/or external purposes
  • Maintaining clinical records in clear required form
  • Aid in the preparation of clinical sections for all regulatory filings (IND, Annual Reports, AE/SAE reporting, study reports, etc.)
  • Collaborate with the research team and external investigators to expand or refine target patient populations
  • Research and identify new opportunities outside of assigned work that augment the company’s mission, vision, values, and goals
  • Accept ownership for accomplishing new and different requests; explore opportunities to add value to job accomplishments
  • Improve quality results by studying, evaluating, and re-designing processes and implementing changes
  • Work across internal departments to maintain credibility, trust, and support of employees and other stakeholders
  • Demonstrate leadership and professionalism to build external relationships crucial to the success of the organization
  • Update job knowledge by participating in educational opportunities; reading professional publications; maintaining professional networks; and participating in professional organizations
  • Perform other duties as assigned by supervisor

  Education, Experience, Skills:

  • S. in scientific or business-related field
  • 10+ years of clinical operations experience and clinical trial design and conduct in either the pharmaceutical or biotechnology industries to include orphan indications and pediatric populations; specific experience in the area of musculoskeletal, neuromuscular and/or rare diseases is desirable
  • Strong knowledge of FDA guidelines including IND and GCP regulations
  • Proficiency in Electronic Data Capture and Clinical Trial Management Systems
  • General computer and software application proficiency