Associate Director, Process Management - Clinical R&D

The Associate Director, Process Management at Eikon Therapeutics will primarily lead project teams in optimizing business processes, producing procedural documents, and collaborating with Business Process Owners to enhance the end-to-end clinical drug development process. This role involves identifying operational gaps, implementing data analytics tools to measure key performance indicators, defining metrics for process effectiveness, and ensuring ongoing inspection readiness for clinical trials.

Candidates for the Associate Director, Process Management position at Eikon Therapeutics should have at least 10 years of clinical drug development experience, preferably within the biotechnology or pharmaceutical industries. A Bachelor's degree is required, or 8+ years of experience with a postgraduate degree. Knowledge of ICH-GCP and EMEA guidelines, as well as experience with systems like Veeva Quality Vault, is highly advantageous.

The Associate Director, Process Management at Eikon Therapeutics will be required to work onsite at least three days a week at one of the company’s locations in California or New Jersey. This hybrid work model fosters collaboration, enabling direct engagement with cross-functional teams and subject matter experts, which is vital for driving business process improvements effectively.

Eikon Therapeutics is committed to employee development and offers opportunities for ongoing education through training programs focused on new operational procedures and clinical systems. The Associate Director will also foster knowledge sharing among teams to ensure adherence to best practices and compliance with regulations in the clinical R&D landscape.

Absolutely! The Associate Director, Process Management role at Eikon Therapeutics is a pivotal position that not only has influence over clinical operational strategies but also opens up opportunities for advancement as the company scales. Your role in optimizing processes and ensuring compliance can significantly enhance your professional visibility and career trajectory within the biopharmaceutical industry.

When answering this question, highlight specific examples of how you've identified inefficiencies in existing processes and the strategies you implemented to improve them. Discuss the outcomes, such as increased efficiency or reduced errors, to demonstrate your impact in previous roles.

Interviewers appreciate when candidates show initiative in professional development. Share the resources you utilize, such as industry publications, webinars, and networking events, and discuss how you apply this knowledge to your work to maintain compliance and enhance operational effectiveness.

In answering this question, choose a specific project that required collaboration across various functional teams. Detail the challenge, the actions you took to lead the team, and the successful outcomes that resulted from your collective efforts.

To address compliance, discuss specific methodologies you implement, such as conducting regular audits, providing training for team members, and keeping informed about regulatory changes. Emphasize the importance of fostering a culture of compliance within the teams you lead.

Use this opportunity to explain your experience with data analysis tools and methodologies. Discuss how you identify key performance indicators (KPIs) and the process you use to evaluate data to drive continuous improvement in operations.

Discuss how effective communication is essential in managing stakeholder expectations, fostering collaboration, and ensuring all team members are aligned. Provide examples of how you’ve used communication strategies to overcome challenges or facilitate project success.

Address this question by discussing your approach to conflict resolution and mentorship. Mention how you would have a candid conversation with the employee, assess the situation, and work together to identify obstacles and solutions to get back on track.

Be prepared to discuss software and tools you've used in previous roles, such as Clinical Trial Management Systems (CTMS), Veeva Clinical Platform, or electronic Trial Master Files (eTMF). Emphasize how these tools aided in efficiency and compliance during clinical development.

Describe your approach to crafting training programs, such as using a variety of learning formats, soliciting feedback from participants, and ensuring accessibility. Discuss how you measure the effectiveness of training and address any gaps identified during implementation.

Articulate a strategic outlook on what effective process management looks like, including elements like agility, responsiveness to regulatory changes, alignment with organizational goals, and fostering innovation within teams. Share how you aim to contribute to achieving this vision at Eikon Therapeutics.