Description

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 Director, Clinical Operations is responsible for the strategic and operational management of clinical studies across Europe, including oversight of CROs, vendors, 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 Director provides leadership across clinical programs, manages and develops Clinical Operations staff, and collaborates with internal and external stakeholders to deliver high-quality clinical data that supports development and regulatory objectives.

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.

Director, Clinical Operations - Europe

Description

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