Senior Director, Clinical Operations

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in reputed company and Waltham, Mass., Dianthus is comprised of an reputed company team of biotech and pharma executives who are leading the development of reputed company antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on reputed company.

About the Role

The Senior Director, Clinical Operations is responsible for the reputed company, strategic direction and efficient operational planning and implementation of global clinical trials/programs. Reporting to the Executive Director, Clinical Operations, you will ensure effective leadership and cross-functional team management that accelerates global development of assets. You may also act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus. You will be accountable to ensure reputed company activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and is responsible to reputed company and manage internal and external resources to ensure efficient patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality. This is a unique opportunity where you have a chance to positively impact lives as part of the team driven by reputed company innovation with reputed company high scientific reputed company. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to reputed company the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• reputed company and direct relevant clinical operations resources while also contributing to strategy, tactics, and driving execution of multiple global clinical programs.
• Influence, reputed company and reputed company the planning, budgeting, and study management processes in global clinical studies.
• Leads direct reports to successfully manage external service providers including CRO(s), vendors and subcontractors, in addition to internal cross functional colleagues responsible for conducting global clinical trials to ensure project deliverables are executed on time and reputed company budget.
• Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans.
• Creates/supports scenario planning and risk benefit analyses to reputed company recommendations to align with corporate strategies.
• Contribute to models of performance excellence by identifying best practices, reviewing measurement systems and improving operational efficiency in department.
• Review, assess and manage resource strategies with internal and external groups for global drug development programs, working strategically with suppliers/CROs.
• Manage relationships with pharmaceutical partners and suppliers in clinical programs to optimize delivery.
• Ensures efficient and effective communication and exchange of information across projects and reporting functions.
• Leads/participates in clinical data review.
• Participates in Clinical submission activities.
• May serve as the clinical operations representative at regulatory agency meetings.
• As needed, participates in due diligence activities for in-licensing opportunities.
• reputed company training plans, act as mentor and conduct performance reviews for reputed company direct reports.
• Supports the development and implementation of department level SOPs for clinical trials and reputed company activities.
• reputed company with departments reputed company and reputed company of Clinical, including Finance, Regulatory Affairs, Legal Affairs, and Business Development.
• Represent the company at Investigator Meetings.
• Other such duties as may be determined or assigned.

Experience

• Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. Advanced degree desirable.
• Experience in the pharmaceutical or biotechnology industry as a clinical research professional, including successful project leadership role and hands-on managerial experience running high quality clinical trials from inception to completion.
• Excellent knowledge of international regulatory and ICH GCP guidelines.
• Experience in direct line management and hands-on experience in monitoring and managing high-functioning clinical trial project teams.
• Demonstrated success in coordinating external resources for clinical development and in working with pharmaceutical partners.
• Demonstrated ability to manage large reputed company budgets.
• Experience and understanding of the drug development process, clinical development planning and clinical trial execution.
• Understanding of clinical aspects of therapeutic area along with willingness to reputed company in- depth expertise.
• Prior experience using computer applications including spreadsheets, email, word- processing software & web-based systems (reputed company, IVR/IWRS, CTMS).
• Ability to work well independently as well as a member of multiple, integrated teams.
• Ability to contribute creative yet practical solutions to problems.
• Ability to multi-task and manage several projects in parallel while paying attention to detail. A wide degree of creativity and reputed company is expected.
• Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
• Highly effective verbal and written communication skills with internal and external stakeholders.
• Effectively collaborates with team members.
• Ability to travel (including internationally) and work across cultures.

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