What are the responsibilities and job description for the Executive Director, Clinical Operations position at Cormedix Inc.?

Why CorMedix?

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If you are interested in joining an entrepreneurial team, focused on bringing life-saving therapies to market for critical unmet medical needs, consider applying for a role at CorMedix. The culture at CorMedix is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare.

CorMedix’s greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose. We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs.

Company Description :

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit : www.cormedix.com.

Position :

The Executive Director, Clinical Operations will lead the strategic and operational direction of clinical programs to ensure the successful execution of clinical trials across all phases. This role is pivotal in driving operational excellence, fostering cross-functional collaboration, and ensuring regulatory compliance while maintaining patient-centric trial designs. The Executive Director, Clinical Operations will oversee the clinical operations team, external vendors, and strategic partnerships, ensuring alignment with the company's mission and objectives.

Primary Responsibilities :

Strategic Leadership

Develop and execute the clinical operations strategy aligned with corporate objectives.
Provide visionary leadership for clinical development programs, ensuring alignment with regulatory requirements and commercial goals.
Serve as a key member of the leadership team, contributing to high-level strategic planning and decision-making.

Operational Oversight

Oversee the design, implementation, and management of clinical trials from initiation to completion.

Using a nimble lens, generate ideas for process improvement, department growth and data optimization.

Manage operational budgets, timelines, and resource allocation to ensure efficient trial execution.

Build and maintain relationships with external partners, including CROs, vendors, and investigators, ensuring quality and performance.

Team Management

Recruit, mentor, and develop a high-performing clinical operations team.

Identify opportunities for individual and team growth, create progressive professional development plans, seek opportunities for cross-training and anticipate needs of both the organization and employees.

Foster a collaborative and inclusive work environment that encourages innovation and excellence.

Foster an environment of psychological safety where team members at every level are encouraged to bring ideas forward, improve processes and contribute to CorMedix’ growth.

Compliance and Risk Management

Ensure adherence to ICH-GCP guidelines, FDA, and other global regulatory requirements.

Identify and mitigate risks across clinical programs, implementing proactive solutions.

Continuous Improvement

Establish and monitor KPIs for clinical operations, driving continuous improvement in processes and outcomes.

Stay current with industry trends, technological advancements, and regulatory changes, integrating best practices into operations.

Has successfully led Clinical Operations at a small / mid-size biotech environment, dynamically updating protocols and processes as the organization grows.

Skills and Requirements :

Strong strategic planning and problem-solving skills.

Exceptional leadership and team-building capabilities.

In-depth knowledge of clinical development processes, regulations, and standards.

Proven ability to manage budgets and resources effectively.

Excellent communication and interpersonal skills, with the ability to influence and inspire cross-functional teams.

Extensive recent and frequent hands-on experience with infrastructure building, program design and establishing a functional area culture.

Qualifications :

Advanced degree in life sciences (PhD, PharmD, or equivalent preferred).

Minimum of 15 years of experience in clinical operations, with at least 5 years in a senior leadership role in the biopharmaceutical industry.

Demonstrated experience managing clinical trials across all phases.

EEO Statement :

CorMedix is an equal opportunity employer. The Company is committed to providing a safe, respectful, and professional work environment that is free from all forms of unlawful discrimination, harassment (including sexual harassment), and retaliation, and complies with all applicable laws prohibiting such conduct. CorMedix does not discriminate against any individual on the basis of race, religion, color, national origin, ancestry, sex, marital / civil union / domestic partner status, family or parental status, sexual orientation, age, disability, or any other status protected under applicable federal, state, or local law.

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Executive Director, Clinical Operations

What are the responsibilities and job description for the Executive Director, Clinical Operations position at Cormedix Inc.?

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