Associate Director, Drug Product

As the Associate Director, Drug Product at Eikon Therapeutics, your responsibilities include overseeing the development and manufacturing processes of drug products, ensuring compliance with all regulatory standards. You'll lead cross-functional teams, develop project plans, manage timelines and budgets, and handle CMC activities while preparing necessary regulatory submissions.

Candidates for the Associate Director, Drug Product role at Eikon Therapeutics should have a postgraduate degree, ideally a PhD, in Pharmaceutics or a related field, along with at least 7 years of relevant experience. Familiarity with FDA and EMA regulations, as well as experience with varied dosage forms, is essential.

Eikon Therapeutics is committed to supporting its teams through mentorship opportunities, professional development, and fostering a collaborative work environment. The Associate Director position will also involve overseeing junior staff development, ensuring a culture of continuous improvement and innovation.

Candidates can expect a thorough interview process that focuses on their leadership abilities, regulatory knowledge, and experience in drug product development. You should be prepared to discuss past projects, your approach to managing cross-functional teams, and how you navigate the regulatory landscape.

Eikon Therapeutics offers a competitive salary range, along with generous benefits including comprehensive medical, dental, and vision insurance, a robust 401k with company matching, mental health and wellness benefits, and a daily subsidized lunch program when on-site. Additional perks include holiday shutdowns and enhanced parental leave.

When answering this question, provide specific examples of drug product development projects you've led, emphasizing the processes you implemented and the outcomes achieved. Highlight your knowledge of regulatory compliance and how you've ensured adherence to industry standards.

Discuss your methodology for prioritization, perhaps using tools like project management software or setting quarterly goals. Emphasize your ability to adapt to change and manage multiple high-stakes projects simultaneously.

In your response, describe a collaborative and inclusive leadership approach. Provide examples of how you've led diverse teams toward successful outcomes, focusing on mentorship and fostering an innovative culture.

Prepare a detailed story to illustrate a specific challenge, including how you approached the problem, the strategies you employed, and what the final resolution was, demonstrating your problem-solving skills and resilience.

Explain how you leverage resources such as industry publications, regulatory agency updates, and professional networks to stay informed about evolving regulations. You could also mention attending workshops or seminars that contribute to your ongoing education.

Talk about the communication strategies you use, regular meetings, and collaborative platforms to ensure all stakeholders are aligned. Emphasize your belief in clear expectations and open lines of communication as keys to successful collaboration.

Provide an overview of the types of regulatory submissions you’ve authored or contributed to, outlining your role in gathering data, writing compelling CMC sections, and ensuring timely submissions to agencies like the FDA and EMA.

Share your philosophy on mentorship, including specific strategies you employ to guide junior staff. Discuss regular one-on-one meetings, goal-setting, and how you provide constructive feedback to help them grow professionally.

Discuss your experience in managing vendor performance through effective communication, setting clear expectations, and negotiating contracts that meet both parties' needs. Highlight any successful partnerships you’ve fostered in your previous roles.

Express your enthusiasm for Eikon Therapeutics' innovative technology and commitment to advancing healthcare. Mention specific aspects of the company’s mission and culture that resonate with you, and how you see yourself contributing to its goals.