Associate Director, Clinical Operations

About Us

We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

The Associate Director, Clinical Operations will be responsible for the oversight, strategic direction and efficient operational planning and implementation of global clinical trials/programs on either a regional or global level.

You will report to the Executive Director, Clinical Development Operations and work with cross-functional team management to accelerate development of clinical assets. As the Associate Director, you may also act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus on either a regional or global basis. You will be accountable to ensure all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and be responsible to oversee 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.

We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Oversee and direct relevant internal and external clinical operations resources while also contributing to strategy, tactics, and driving execution of global clinical studies at a regional or global level
• Influence, oversee and support or lead the planning, budgeting, and study management processes in global clinical studies.
• Leads and supports internal cross functional colleagues to successfully manage external service providers including CRO(s), vendors and subcontractors responsible for conducting global clinical trials to ensure project deliverables are executed on time and within budget at a regional or global level.
• Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans.
• Creates or supports scenario planning and risk benefit analyses to make 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 studies/programs to optimize delivery.
• Ensures efficient and effective communication and exchange of information across the project and reporting functions.
• May participate in Clinical submission activities.
• Lead or participate in clinical data review
• Supports the development and implementation of department level SOPs for clinical trials and related activities.
• Interface with departments within and outside of Dianthus including Finance, Regulatory Affairs, Legal Affairs, and Business Development.
• Represent the company at Investigator Meetings.

Experience

• Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. Advanced degree desirable.
• 10+ years of experience in the pharmaceutical or medical device 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 or matrix team 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 complex 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 develop in-depth expertise.
• Prior experience using computer applications including spreadsheets, email, word-processing software & web-based systems (EDC, 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 latitude 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.

Originally posted on Himalayas