Edgewise Therapeutics

Develops therapies for rare muscular disorders

Associate Director - Clinical Operations

Clinical Research OperationsConfirmed live in the last 24 hours

Full-time

About the Job

Requirements

A B.S./B.A. in nursing, in a scientific field, or in a business-related field.
At least 12 years of clinical operations experience in rare disease and/or cardiac clinical trial design and conduct.
Strong knowledge of Food and Drug Administration guidelines, including Investigational New Drug and Good Clinical Practice regulations.
Proficiency in electronic data capture and clinical trial management systems.
Experience in both late- and early-phase clinical trials.
Strong clinical knowledge.
Clinical monitoring and auditing experience.
Experience managing clinical operations teams.
Ability to develop and execute plans in a fast-paced environment.
Significant leadership and management experience in the industry.
Analytical and problem-solving skills, with the ability to think strategically.
Interpersonal skills and ability to work across numerous scientific disciplines.
Written and verbal communication skills.
Ability to develop operational strategy for programs and associated studies, including timelines, communication plans, risk management and contingency plans, and budgets at the program and study level.

Responsibilities

Drive execution of clinical trial plans to deliver safety, pharmacokinetic, and efficacy data supporting regulatory and marketing proof-of-relevance.
Identify and evaluate contractors for clinical studies, including negotiating pricing and timelines with contract research organizations, sites, and central laboratories.
Serve as the primary contact for contract research organizations, sites, and central laboratories on study matters, including clinical planning, patient recruitment, protocol compliance, and progress monitoring from start-up through final study report writing.
Establish critical timelines and direct employees, collaborators, clinical sites, and clinical investigators to meet deadlines and target goals.
Devise and implement budgets, cost controls, and resource plans to meet corporate objectives.
Work with the contracted data management team on electronic case report forms to ensure 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.
Review and challenge project team members’ work while offering input and solutions.
Contribute to recruiting, retaining, and developing scientific, regulatory, and clinical personnel.
Lead development team meetings, including planning, guiding, and directing content and participation.
Influence collaborators and consultants through understanding of company projects, data, results, and objectives.
Craft, review, and approve clinical reports and presentations for internal and external use.
Maintain clinical records in the required form.
Assist in preparing clinical sections for regulatory filings, including Investigational New Drug submissions, annual reports, adverse event and serious adverse event reporting, and study reports.
Manage operational excellence teams to drive best practices across Clinical Operations and development within a matrix organization.
Manage Associate Director-level staff and below.
Report study or program milestones to senior and executive management.
Serve as a point of contact for strategic partnerships with external partners as needed.
Identify key consultants and establish collaborations.
Participate in strategic meetings.
Collaborate with research teams and external investigators to expand or refine target patient populations.
Review and approve clinical scientific documents and standard operating procedures.
Support due diligence efforts and regulatory submissions.
Deliver projects and programs on schedule and within budget.

At Edgewise, we are focused on advancing novel, muscle-targeted therapeutics for serious cardiovascular and cardiometabolic conditions with significant unmet need. Leveraging our expertise in muscle biology and small molecule drug development, we are building a cardiovascular pipeline that includes programs for hypertrophic cardiomyopathy, heart failure and other serious cardiovascular diseases.

We’re building a passionate, experienced team committed to tackling complex scientific and clinical challenges and delivering meaningful outcomes for patients. If you’re looking to do work that matters, we’d love to hear from you.

About the Position:

The Associate Director, Clinical Operations is responsible for the strategic and operational management of clinical studies across Europe, including oversight of CROs, vendors, central laboratories, and clinical sites. This role leads study execution from planning through final reporting, ensuring timelines, budgets, quality standards, and regulatory requirements are met. The Associate Director provides leadership across one or more clinical programs, drives cross-functional collaboration, and works closely with internal and external stakeholders to deliver high-quality clinical data that supports development, regulatory, and business objectives. Additionally, this individual contributes to Clinical Operations strategy, supports regulatory submissions, and helps foster operational excellence within a matrix organization.

Essential Job Duties and Functions:

Drive execution of clinical trial plans to deliver compelling safety, pharmacokinetic, and efficacy data supportive of regulatory and marketing proof-of-relevance.
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.
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.)
Responsible for managing multiple operational excellence teams to drive best practice across Clinical Operations and development within a matrix organization.
Has line management responsibility Associate Director level staff and below.
Interacts with senior and executive level management to report on study or program milestones.
May be the point of contact for more strategic partnerships with external partners.
Works extensively with team members.
Identify key consultants and establish valuable collaborations.
Participates in strategic meetings.
Collaborate with the research team and external investigators to expand or refine target patient populations.
Expert knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
Proven ability to build a team in which the expertise resides.
Demonstrated capability for continued upward growth and technical contributions.
Able to review and approve clinical scientific documents and SOPs.
Experience supporting due diligence efforts and/or regulatory submissions.
Successful track record of delivering projects/programs on schedule and within budget.
Solid understanding of overall business needs.
Adapts management style to different situations independently.
Advanced knowledge of financial systems, processes and reports.
Advanced knowledge of developing targeted performance standards to drive operational performance.

Required Education, Experience and Skills:

B.S./B.A. in nursing, in scientific or business-related field.
12+ years of clinical operations experience in in rare disease and/or cardiac clinical trial clinical trial design and conduct.
Strong knowledge of FDA guidelines including IND and GCP regulations.
Proficiency in Electronic Data Capture and Clinical Trial Management Systems.
Late and early phase experience.
Strong clinical knowledge.
Clinical monitoring and auditing experience.
Experience managing clinical operation teams.
Thinks creatively and develops and executes plans within a fast-paced environment.
Significant leadership and management experience in the industry.
Excellent analytical and problem-solving skills, with the proven ability to think strategically.
Highly effective interpersonal skills and the ability to work across numerous scientific disciplines.
Creates belonging in a team by integrating teammates.
Excellent written and verbal communication skills.
Demonstrated ability to develop operational strategy for programs and the associated studies, including development of timelines, communication plans, risk management/ contingency plans and budgets at the program and study level.

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this 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 Company

Edgewise Therapeutics

Develops therapies for rare muscular disorders

Edgewise Therapeutics develops therapies for rare muscle disorders using a proprietary drug discovery platform. Its lead molecule, sevasemten (EDG 5506), targets the muscle motor protein myosin to reduce stress in fast skeletal muscle fibers, aiming to improve muscle health without affecting other muscle types. The company owns global development and commercialization rights to its programs and pursues strategic collaborations and asset acquisitions to accelerate its pipeline. Its focus is precision medicine for conditions like Duchenne muscular dystrophy, Becker muscular dystrophy, Limb Girdle muscular dystrophies, and McArdle disease. Overall, Edgewise seeks to deliver targeted treatments that protect and improve muscle health for patients and families affected by these rare diseases.

Company size: 51-200
Company stage: IPO
Headquarters: Boulder, CO
Founded: 2017

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