Director, Process Management - Clinical R&D

The Director, Process Management at Eikon Therapeutics is responsible for providing strategic oversight for business process design, optimization, and scaling to align with Clinical R&D goals. This involves leading project teams in developing procedural documents, collaborating with cross-functional teams, and implementing data-driven tools to measure process effectiveness.

To qualify for the Director, Process Management position at Eikon Therapeutics, candidates should have at least 12 years of clinical drug development experience with a Bachelor's degree, or 10 years with a postgraduate degree. Experience in the biotechnology or pharmaceutical industry is crucial, along with knowledge of ICH-GCP guidelines and regulatory standards.

The Director, Process Management role supports team growth at Eikon Therapeutics by ensuring processes are designed for scalability and efficiency, thereby enabling the Clinical R&D team to expand effectively as new personnel and projects are added. This strategic alignment allows for better collaboration and higher performance across studies.

Directors, Process Management at Eikon Therapeutics utilize a variety of tools to collect relevant data, identify key performance indicators (KPIs), and perform data-driven analyses. These tools assist in defining metrics to monitor process effectiveness and facilitate ongoing improvement initiatives.

Beneficial experience for the Director, Process Management position at Eikon Therapeutics includes a strong background in clinical drug development processes, experience with process optimization in a highly regulated environment, and familiarity with platforms like Veeva Quality Vault and Veeva Clinical Platform.

In answering this question, detail specific projects where you identified inefficiencies and implemented improvements. Discuss the methodologies used and the measurable outcomes of your initiatives.

To address this question, share your understanding of relevant regulations like ICH-GCP and describe how you've integrated compliance checks into process documentation and training programs.

Illustrate your leadership qualities by recounting a project example, highlighting the challenges faced, your team-building strategies, and the successful outcome due to effective collaboration.

Talk about your approach to change management, which can include open communication, soliciting feedback, and providing comprehensive training to help your team feel supported during transitions.

Mention key performance indicators that are relevant to clinical trials, such as timelines, cost efficiency, error rates, and regulatory compliance, and explain why they are vital for success.

Stress the importance of mediation and conflict resolution skills. Provide an example of how you addressed a conflict, focusing on communication and collaboration to resolve the issue productively.

Detail any hands-on experience with clinical systems such as Clinical Trial Management Systems, discussing the challenges and successes encountered during system implementations.

Share your strategies for professional development, such as attending conferences, participating in industry forums, or being involved in relevant professional organizations to stay informed.

Discuss your systematic approach to documentation, ensuring clarity, compliance, and accessibility. Share an instance where proper documentation played a significant role in a project’s success.

Express your alignment with Eikon’s mission and values, and share specific reasons, such as the innovative culture or the potential impact of your role in advancing clinical R&D at Eikon.