Careers

Current Openings

Accounts Payable Specialist

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the position:

This position provides financial and administrative support by ensuring payments are completed and expenses are controlled by processing, verifying, and reconciling invoices and expense reports according to established policies and procedures in an efficient, timely, and accurate manner.

Responsibilities:

  • Review invoices, ensure proper documentation and approvals, compute self-assessed sales tax when applicable
  • File use tax returns with state and city
  • Reconcile and process invoices in timely manner in Coupa and NetSuite
  • Reconcile, review coding, and process all employee expense reports
  • Prepare a weekly payment run for vendors and employee reimbursements
  • Process wires and any rush payments as needed
  • Setup new wire templates as necessary; periodically confirm information has not changed
  • Input payments for non-ACH transactions into NetSuite
  • Prepare journal entries related to the accounts payable process
  • Assist in the month-end financial close process
  • Add new vendor information and update vendor information as needed in NetSuite
  • Review W-9 and or W-8 forms and intake forms for all vendors, 1099 maintenance in NetSuite
  • Prepare end of year 1099 reporting
  • Assist employees and train new employees on purchasing and approving invoices in Coupa
  • Communicate directly with vendors and employees in resolving issues within the AP process
  • Maintain discretion and confidentiality in all company business/relationships
  • Improve quality results by studying, evaluating, and re-designing position processes and implementing changes
  • Assist in execution and documentation of internal controls over financial reporting (SOX)
  • Work across internal departments to maintain credibility, trust, and support of employees and other stakeholders
  • Demonstrate professionalism to build external relationships crucial to the success of the organization
  • Perform additional duties as requested by supervisor

Requirements:

  • High School Diploma
  • 3+ years of purchasing, accounts payable or accounting experience
  • Experience in Coupa and Netsuite preferred, but not required
  • Highly organized, detail oriented with a high level of accuracy
  • Able to work comfortably with different systems and problem solve
  • Have strong interpersonal skills with the ability to effectively engage different personality types
  • Pro-active and able to work effectively in a team environment
  • Able to work well under pressure with multiple tasks and deadlines
  • Well written with excellent verbal communication skills

Salary range: $55,000 to $70,000. Level and salary will depend on experience level.

Send resume and cover letter to recruiting@edgewisetx.com


Associate Director/Director, Regulatory Affairs CMC

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

This position manages the successful operation of the department and provides regulatory expertise.

Primary responsibilities:

  • Responsible for regulatory CMC strategy for product development and registration for small molecule investigational products. Conduct risk assessments and recommend development options.
  • Oversees the writing, editing, reviewing and compiling CMC documents needed for regulatory submission activities for US and global assigned products. The submissions include IMPD, INDs, CTAs, NDAs, MAAs, meeting requests, briefing documents, and annual reports, and well as contribution from a CMC perspective on other submissions and clinical documents
  • Participation in Health Authority interactions on CMC matters.
  • Provides critical review of CMC documentation supporting regulatory submissions and communications.
  • Collaborate cross-functionally with Regulatory Affairs, CMC, and Quality to ensure compliance such as manufacturing records review, release and change controls.
  • Provide leadership for regulatory document management systems and maintain regulatory files.
  • Ensures CMC regulatory milestones are met to support regulatory submission and overall business goals of the Company,
  • Contribute to the development of the overall 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
  • 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 CMC Regulatory Affairs
  • 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: Starting salary $130,000 – $200,000 depending on experience.

Send resume and cover letter to recruiting@edgewisetx.com


Director, Quality Assurance

 

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the position:

 

Edgewise is seeking an experienced biotech/pharma quality assurance leader. The Director, QA will enhance and maintain a quality system compliant with applicable GCP requirements to support Edgewise Clinical Development activities.

Responsibilities:


  • Clinical Vendor Qualification and Compliance:
  • Track the active clinical vendors supporting Edgewise Clinical Trials
  • Manage compliance oversight of active clinical vendors contracted to perform GCP activities
  • Interface directly with CROs to develop and amend clinical quality agreements and management of quality-related issues
  • Plan, and perform audits of clinical vendors to ensure compliance with the FDA and other worldwide health authority GCP regulations/guidelines, vendor SOPs, protocols, and industry standards
  • Prepare clear and concise written audit reports, including audit observations and 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    

  • GCP Quality Management System:
  • Oversee, and provide phase appropriate updates to, the GCP Quality Management System
  • Generate, review, approve, and maintain SOPs
  • Improve quality results by studying, evaluating, and re-designing processes and implementing changes
  • Collaborate with SMEs (subject matter experts) to ensure compliant and technically sound investigations, corrective actions, change controls and process related documents
  • Support review of internal and external investigations, , CAPA, and effectiveness checks to provide quality assurance feedback; track records to ensure proper resolution and closure
  • Provide document management assistance to Departments and SMEs for retention and archival of quality system records

  • Clinical Operations and study oversight:
  • Maintain appropriate communications to monitor Clinical Trial plans and status
  • Plan, perform and report audits of internal Edgewise GCP activities
  • Create and execute audit plans for clinical study sites Oversee delegation of any GCP audit activity
  • Advise on GCP compliance, deviations to SOPs and Protocols, and potential clinical trial quality issues
  • Review clinical study protocols and other study related documentation, as appropriate    

  • Training:
  • Manage internal and external training on GCPs for clinical staff and clinical investigators

  •  Inspection Readiness:
  • Develop and Implement BIMO inspection readiness plans for Edgewise clinical programs
  • Support BIMO (and other regulatory) inspections of Edgewise, clinical vendors, and clinical investigator sites
  • Assist in development of responses to regulatory inspection findings, as appropriate

  • Regulatory Intelligence and Support:
  • Stay abreast of significant changes to worldwide GCP regulations and guidelines
  • Plan and execute audits of appropriate sections of NDA regulatory submissions to ensure consistency, accuracy and completeness

  • Quality Operations:
  • Develop and communicates budget and resource needs to support GCP Quality activities
  • Supervise Clinical Quality and consultant personnel, as required

  •  

Requirements:

  • B.S. in scientifically-related field
  • 10+ years of clinical quality assurance experience, including planning and performing quality system audits, in a pharmaceutical development organization
  • Extensive knowledge of GCP regulations and SOP implementation; experience in GLP and/or GMP Compliance would be a plus
  • Proven ability to build a strong and flexible Clinical Quality team
  • Build, Manage and Maintain a clinical QMS
  • 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, organizational 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: $170,000 to $220,000. Level and salary will depend on experience level.

 

Send resume and cover letter to recruiting@edgewisetx.com


 

 


Manager/Associate Director, Data Management

 

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

 

About the Position

This position will serve as the in-house Data Manager responsible for providing oversight to the CRO Data Management team across the program. This role will consult and collaborate with all functions within the clinical development team, as necessary and report into the Vice President, Clinical Development Operations.

 

Primary Responsibilities

  • Manage the performance of Clinical Research Organizations (CRO) performing data management activities
  • Oversee/contribute to Case Report Form development and database development and modifications
  • Responsible for all DM activities from start-up, conduct, and closeout
  • Ensure appropriate PK and PD and PK/PD data analyses including population PK, PK/PD modeling and simulation are conducted for each study/program
  • Lead/drive project deliverables and timelines and development teams and provide input into assay development, CRO selection and CRO management
  • Review and approve clinical trial documentation, such as protocol, timelines, Data Management Plan, Case Report Form Completion Guidelines, and other documentation
  • Draft, review and finalize internal data management documentation
  • Participate/lead Sponsor Acceptance Testing
  • Perform data cleaning and external vendor data reconciliation
  • Collaborate/work with Biostatisticians, Statistical Programmers, Medical Monitors and Clinical Operation Trial Lead, Pharmacovigilance, Regulatory Affairs, and other line functions/departments on clinical trials
  • Participate/lead in data management and cross-functional project clinical trial meetings
  • Develop and communicate requirements, timelines, strategy, and deliverables both internally and externally to ensure achievements are met
  • Manage/perform other duties as needed

Requirements:

  • B.S. in a scientific field with 5-7 years of data management experience in CRO/pharma/biotech setting
  • At least 2 years’ experience as a Lead/Program Data Manager preferred
  • Proficient in clinical data collection, cleaning, and analysis for clinical trials
  • Experience in rare disease required; neuromuscular and / or pediatrics experience preferred
  • Experience working in an outsourced Data Management model
  • Experience with EDC systems is required; Medidata Rave experience a plus
  • Solid understanding of ICH GCP as well as general knowledge of industry practices and standards (CDASH, SDTM)
  • Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
  • Interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills
  • Ability to self-motivate and lead with confidence is critical
  • Excellent organizational and time management skills, sense of urgency
  • Strong analytical and problem-solving skills
  • Project Management skills

 

This is a remote position, ideally situated on the east coast.

Salary range: $100,000 – $170,000, title and salary commensurate with experience

 

Send resume and cover letter to recruiting@edgewisetx.com

 


Scientist, Drug Metabolism and Pharmacokinetics (DMPK)

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

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.

Primary Responsibilities

  • 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

Requirements:

  • 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

Send resume and cover letter to recruiting@edgewisetx.com


Senior Scientist, Medicinal Chemistry

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

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 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: $125,000 – $225,000. Salary will depend on experience level.

Send resume and cover letter to recruiting@edgewisetx.com


Senior Scientist, Pharmacology

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage biopharmaceutical company focused on rare muscle disorders.

About the Position

Cardiovascular scientific position with for an upcoming leader in the field capable of both performing and leading multi-omics, molecular, in vitro, and in vivo scientific efforts. Broad range of responsibilities, including designing, managing, and executing high-quality experiments, establishing, and managing collaborations, analyzing and reporting data, and contributing intellectually to scientific research as it relates to advancing company goals. The Senior Scientist may be responsible for leading a project group.

Primary Responsibilities:

  • Independently design, manage, and execute experiments in context of scientific goals across the company’s ongoing projects
  • Conduct and/or manage a team that conducts detailed and complex wet laboratory experiments with appropriate technique and adequate controls satisfactory to substantiate/replicate results
  • Contribute to the coordination and direction of research among the company’s scientific disciplines as they relate to assigned projects
  • Manage a group of independent researchers
  • Research and identify new opportunities and project ideas outside of assigned both the work and the company that complement the company’s mission, vision, values, and goals
  • Establish appropriate objectives in the formulation of successful project strategy
  • Influence the direction of company programs by designing experiments and collaborations, interpreting, analyzing, and correlating data from multiple sources, overcoming obstacles, and delivering results within project timelines
  • Demonstrate a high level of resourcefulness through exceptional scientific knowledge and superior technical skills
  • Actively increase team or group performance by critically reviewing work processes while offering insightful input and suggestions
  • Produce and review individual and team scientific reports/presentations for internal and/or external purposes
  • Work closely with consultants and collaborators to understand results and how they impact project goals
  • Demonstrate a strong level of participation at project team meetings
  • Maintain scientific records in clear required form
  • Contribute advanced-level scientific perspective to patent efforts
  • Update job knowledge by attending scientific meetings; 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

Requirements:

EDUCATION, EXPERIENCE, SKILLS:

  • Ph.D. in cardiovascular physiology or closely related field; post-doctoral and industry experience required
  • 7+ years of academic/research laboratory experience
  • Exceptional understanding of scientific literature in respective area of science/research
  • Demonstrated cardiovascular expertise (publication track record)
  • Technical expertise in both in vitro and in vivo cardiovascular techniques across a range of species, with strong molecular and multi-omics expertise
  • Demonstrated ability to work independently and to lead independent scientists
  • Familiarity with safe and efficient laboratory practices
  • General scientific computer and software application proficiency

Salary range: $120,000 – $190,000. Salary will depend on experience level.

Travel: The preference is to have this position based in Colorado. If the incumbent is not local, a hybrid situation with 50% time on-site would be acceptable.

Send resume and cover letter to recruiting@edgewisetx.com