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.
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.
- 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
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
Salary range: $80,000 – $140,000. Salary will depend on experience level.
About the Position
This position manages the successful operation of the department and provides regulatory expertise.
- Oversees the writing, editing, reviewing and compiling documents needed for regulatory submission activities for US and global assigned products.
- Provides critical review of all documentation supporting regulatory submissions and communications.
- Prepares and submits regulatory applications, annual reports/IND amendments, and meeting requests to FDA and European regulatory agencies.
- Reviews and prepares responses to requests from regulatory authorities.
- Provides leadership for regulatory document management systems and maintains corporate regulatory files.
- Ensures regulatory milestones are met to support regulatory submission and overall business goals of the Company,
- Contribute to the development of regulatory strategies
- Research and identify new opportunities outside of assigned work that augment Company’s mission, vision, values, and goals
- Effectively manages and mentors regulatory staff
- Leads regulatory operations efforts for development programs by working closely with internal functional teams, external vendors and consultants
- Oversees the external vendors and contractors with responsibility for providing regulatory support to ensure goals are achieved
- Primary liaison with regulatory agencies § Interacts with senior management to report on project or program milestones
- Provides strategic or operational input on project team
- Builds professional and effective external relationships crucial to the success of the organization
- Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders
- Fully involved and responsible for all areas of communication with FDA and other government regulatory authorities
- Other duties as assigned
Education, Skills and Other Requirements:
- BS/BA degree in a scientific/health sciences discipline
- 7+ years experience in pharmaceutical Regulatory Affairs
- 3 years of supervisory experience
- Experience in the preparation of submissions, regulatory documents, annual reports, amendments and supplements
- Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan
- Management expertise on the timeline and process for submissions
- Expert knowledge of regulations and guidance’s affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment
- In-depth knowledge of overall global drug development
- Excellent written, interpersonal and communication skills
- Action oriented and committed to meeting FDA and other regulations while moving projects forward
- Able to handle changing priorities and multidisciplinary tasks
- Easily gains trust and support of peers; encourages collaboration
- Strong project management skills
Salary range: $120,000 – $170,000. Title and salary will depend on experience level.
About the Position
The Animal Care Technician is responsible for providing exceptional animal care to the research animals at Edgewise Therapeutics. This includes performing daily husbandry and care and of laboratory animals as well as daily small animal dosing. The right candidate will be a self-motivated individual capable of working to time-sensitive deadlines while maintaining industry standards in accordance with Edgewise’s standard operating procedures. We are looking for a motivated, hardworking individual with a positive work ethic and a passion for working with animals. This position will require working rotating weekends, holidays, and overtime.
Animal Care Technician
The Animal Care Technician is responsible for providing exceptional animal care to the research animals at Edgewise. This includes performing daily husbandry and care and of laboratory animals as well as daily small animal dosing.
The Animal Care Technician is also responsible for performing animal technical procedures and providing animal study support with supervision. The Animal Care Technician will work as part of a team conducting routine procedures required for vivarium operation. Individuals must demonstrate strong communication skills and be able to work efficiently in individual and team settings.
- Provide food, water, and clean housing to rodents according to SOPs
- Perform daily health observations with demonstrated ability to recognize and report abnormalities and common signs of illness.
- Handle and restrain rodents
- Assist with and perform small animal dosing by various routes of administration (e.g. SC, IP, PO, IV)
- Assist our in vivo research team by carrying out study setup and support activities as directed
- Maintain accurate records (e.g. documentation of various facility procedures & metrics
- Perform routine facility sanitation procedures; maintain a clean, clutter-free facility
- Prepare and stock room supplies as needed
- Monitor and record facility environmental parameters
- Perform euthanasia and necropsy procedures as directed
- Operate husbandry-related equipment (air flow hoods, etc.) using approved procedures
- Maintain work area in an organized, clean, and safe condition
- Other duties as assigned
Skills, Experience and Other Requirements:
- Must be able to work in a laboratory setting with direct exposure to/handling of laboratory animals
- Overtime and weekend work as required
- May work with potentially hazardous substances not limited to known /potential teratogens or carcinogens
- Work will require PPE (personal protective equipment)
- Ability to perform repetitive tasks quickly and efficiently
- Accurately calculate and record numbers
- Good teamwork skills
- Must be able to stand for long periods of time
- Must be able to perform all physical aspects required of position including periodic lifting items up to 50 lbs. and moving racks or large items on wheels
- Demonstrated ability to communicate
- Computer proficiency (Microsoft Word and Excel)
Standard Shifts Available Include:
- Wednesday – Sunday (preferred)
- Flexibility in standard shift scheduling may be available if willing to work weekends.
- Shift starts at 7:30am
- Flexibility in standard shift scheduling may be available if willing to work weekends if consistent start time can be maintained with other animal technicians.
Starting pay is $20.00 – $27.00/hour depending on experience
Position with a broad range of duties providing administrative and operations support to Clinical Development, including Operations, Regulatory, Program Management and Advocacy.
- Arrange and manage clinical development meetings, events, meals, functions, and special projects
- Maintain appropriate clinical development administrative and archival files
- Research, prioritize, and follow-up on incoming issues; determine appropriate course of action, referral, or response
- Coordinate formal approval of documents from department
- Develop travel itineraries and agendas; coordinate logistics of off-site meetings for east coast-based clinical department members
- Collaborate with Edgewise’s Administrative Assistant on office management responsibilities
- Maintain discretion and confidentiality in relationships with all clinical and executive matters
- Work with clinical development stakeholders to assist with accounting, legal and clinical processes
- Assist legal with clinical development-related contract flow and communication needs where possible (CDAs)
- Ensure optimal workflow within internal systems by developing expertise in those systems (examples: to generate contracts and P.O.s and pay invoices)
- Track and reconcile invoices including dates, accounting categorization, approvals, P.O. numbers, and date of payment.
- Upload accounts payable information to shared with Accounting once invoices are approved, matched with their P.O.s, and categorized, so that Accounting can process for payment.
- Work across clinical development departments and other appropriate departments to maintain credibility, trust, and support of employees and other stakeholders, many of whom are working remotely
- Enhance company’s reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
- Improve quality results by studying, evaluating, and re-designing office processes and implementing changes
- Support company literature reference filing with appropriate software; request scientific literature as needed
- Prepare and edit routine correspondence and documents
- Follow up on assignments to ensure decisions are implemented and appropriate resources are allocated
- Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures
- Performing other duties as assigned
Education, Experience and Skills Requirements:
- High School Diploma, college degree preferred
- 5+ years of administrative office experience
- Strong communication skills – written and verbal
- Attention to detail
- Advanced skill level in computer applications including word processing, spreadsheets, database, and presentation/graphic software; and Adobe Acrobat
Pay range: $22 – $38 per hour depending on experience.
About the Position
Edgewise is looking for a self-motivated scientist who wants to advance drug discovery programs into the clinic. You will have an opportunity to be a functional area lead developing novel sarcomere targeting small molecule modulators in rare skeletal and genetic cardiac diseases. We are looking for a teammate who shares our passion for drug discovery and seeks a scientifically rigorous and collaborative environment. Role: You will be the functional area representative for DMPK on multidisciplinary discovery project teams. As a member of the discovery team, you will work cross-functionally and as needed with external CROs. The successful candidate will actively contribute to the generation and assessment of study results that support our discovery efforts.
- Coordinate in vitro ADME and in vivo pharmacokinetic studies with our CRO partners.
- Analysis, interpretation, integration, and reporting of pharmacokinetic data and pharmacokinetic/pharmacodynamic (PK/PD) data to support discovery/preclinical projects.
- Participate and contribute to discovery/preclinical development project teams.
- Assist in design and execute preclinical studies to understand ADME characteristics of drug candidates.
- Ability to independently review and summarize results.
- Clear communication of ADME/PK results at project team meetings and other meetings as needed.
- Author regulatory documents to support FIH programs
- Ph.D. (or equivalent degree plus years’ experience) in Pharmacokinetics, Pharmacology, Pharmaceutics, Engineering or other relevant field with >3 years of experience in the biopharmaceutical industry
- Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles.
- Proficient knowledge of ADME/DMPK assays and assessments used in drug discovery and drug development (e.g., in vitro stability, DDI, preclinical pharmacokinetics, and in vitro and in vivo correlations, etc.).
- Experience in PK and or PK/PD analysis using WinNonlin.
- Experience in serving on project teams in early discovery.
- Previous experience working with external CROs.
- Working knowledge of IND and regulatory submissions is helpful.
- Articulate, open communicator (both oral and written) with the ability to analyze, interpret and present data in a clear manner
Salary range: $80,000 – $140,000, title and salary commensurate with experience
About the Position
The Program Management function sits within Clinical Development at Edgewise Therapeutics and is responsible for strategic program and portfolio management of all preclinical and clinical-stage programs from lead nomination to licensure. Edgewise is seeking an experienced and motivated leader to define and execute strategy and development plans in partnership with cross-functional teams.
Reporting directly into the Chief Medical Officer, the Head of Program Management will be responsible for understanding the Company’s candidate drug pipeline and optimize program execution while mitigating risks and planning for contingencies. They will facilitate an innovative program management model, leveraging infrastructure, tools and technologies to maximize productivity and reporting on Edgewise programs. With expectations of continued growth, emphasis will be placed on the recruitment, development and accountability of a high performing team capable of working across all clinical programs. In addition, this role will establish Program Management best practices as applied to R&D programs across the portfolio.
The successful candidate will have deep program management experience across a complex portfolio, and multiple phases of clinical development including preclinical through late stages (Phase 3, submission, post-authorization, and lifecycle management).
The ideal candidate will demonstrate expertise in the following key areas:
- Create a center of excellence for project management at Edgewise and deploy cutting edge practices, tools and technologies, including the implementation and/or optimization of core Program Management measures for reporting, tracking, budget creation and management, integration across functional areas, scenario-planning, and risk mitigation and management.
- Understand and inspire the big picture of drug development program strategy, operations and cross-functional interdependencies in order to develop efficiencies and create a model for the integration and execution of programs across the organization.
- Leverage understanding of the development pipeline to assure alignment with executive management, cross- functional stakeholders, and enterprise priorities.
- Be a thought partner to the senior management team to problem-solve, implement strategies that drive maximum potential realization, and shape the direction of the program.
- Define program strategy in collaboration with functional leaders from candidate selection through key clinical milestones; drive program strategy with continuous focus on innovative approaches and improvement
- Manage programs and drive effective decision-making at the Development Team Level through:
- Proactively identifying and escalating gaps and challenges.
- Managing the team through scenario planning to solve problems.
- Summarizing complex topics into critical points and proactive communication that is outcome and solution-driven.
- Effective meeting management, communication, and oversight of action item completion and decision tracking.
- Communicate program strategies, status, risks, mitigation strategies clearly and concisely to executive management
- Masters degree with 10+ years of experience in a biotechnology or pharmaceutical setting, Ph.D. preferred.
- Project/program management training or certification preferred
- Extensive drug development knowledge and ability to work across key functional areas to understand, define, and execute innovative programs
- Demonstrated experience leading cross functional project teams across the spectrum of early preclinical programs to late-stage clinical programs including strong interpersonal skills in order to influence and motivate others towards a common goal
- Expertise with critical project management tools, software, and implementation strategies to establish processes and practices to efficiently move programs forward, capture and store data and decisions. Previous experience building, managing and leading high performing teams, coaching and mentoring others to enhance performance and/or facilitate career progression.
- Adaptive leadership style and ability to influence team direction without formal reporting authority.
- Ability to work in a fluid environment and foster a strong collaborative spirit internally and externally.
- Strong EQ and personal skills to influence without authority, motivate others and manage conflict
Salary range: $200,000 – $300,000, title and salary commensurate with experience
About the Position
The Head of CMC is responsible for providing strategic leadership, management and direction for all of the Corporation’s drug substance and drug product development activities. The Head of CMC will design, develop and execute long term strategies into short term goals for CMC related activities, in alignment with department, company and commercial goals.
This position will be expected to lead and collaborate with multiple internal stakeholders to ensure that all programs are implemented in accordance with project team strategies and in compliance with global regulatory agencies, and that overall business strategies are translated to guarantee optimal time to market for each of the Corporation’s product candidates.
- Provide oversight and leadership for all process chemistry, GLP, and GMP activities consistent with FDA Guidance across the company’s development portfolio
- Establish the development plan and lead associated pre-formulation/characterization activities for dosage development of drugs from pre-clinical through commercial development.
- Select/recommend third-party manufacturers working with Quality and Regulatory, and assist in the negotiation of effective supply and technical agreements.
- Identify contract analytical laboratory sites required to guide and support third party manufacturing relationships.
- Direct/oversee contract manufacturing, packaging and labeling operations for the company’s drug substances and drug products.
- Act as primary liaison with contractor(s) on assigned projects.
- Guide external operations through tech transfer, process and method development, optimization, qualification and validation of the activities related to all manufacturing operations.
- Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required.
- Work with Quality Assurance to develop and maintain SOPs and guidelines related to the production, planning, disposition and management, materials, etc.
- Work with Regulatory, QA and Senior Management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations.
- Maintain knowledge of current best practices of drug delivery. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate.
- Development plan design and execution to support global regulatory submissions.
- Actively participate in regulatory filings preparation (domestic and international) working with Regulatory and Quality.
- Develop production plans to support clinical and commercial development and adjust plans as appropriate to meet corporate objectives.
- Provide comprehensive project analysis to senior management as required in the form of reports or presentations.
- Participate in the ongoing development and prosecution of the Corporation’s intellectual property portfolio
Education, Experience, Skills
- Master’s in science (chemistry) discipline; Ph.D. in scientifically-related field is preferred.
- 15+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment.
- 7+ years of management and oversight of CDMOs for GLP and cGMP activities from Phase 1 through Phase 3.
- Subject matter expert with exceptional command of scientific literature in the field and related disciplines.
- Proficient in computer applications.
Salary range: $200,000 – $300,000, title and salary commensurate with experience