Director, Pharmaceutical Development

The Director of Pharmaceutical Development at Septerna plays a vital role in managing pharmaceutical development across small molecule drug discovery. Responsibilities include form and formulation development, overseeing GMP manufacturing, collaborating with cross-functional teams, and ensuring timely delivery of drug products for non-GLP studies and clinical trials. Additionally, the director develops CMC strategies, manages regulatory documentation, and ensures high-quality product standards.

Candidates for the Director of Pharmaceutical Development role at Septerna should have a BS, MS, or PhD in pharmaceutics, pharmaceutical sciences, or chemical engineering, along with 10-16 years of relevant industry experience. A strong track record in pharmaceutical development, particularly in small molecule formulation and an understanding of regulatory guidelines is crucial, as is proficiency in quality systems and analytical techniques.

The Director of Pharmaceutical Development at Septerna collaborates closely with cross-functional teams including Medicinal Chemistry, DMPK, Toxicology, and Clinical Pharmacology. This interdisciplinary approach is integral for achieving project goals, managing multiple priorities, and ensuring that drug development processes align with regulatory standards and timelines.

The anticipated salary range for the Director of Pharmaceutical Development position at Septerna is $215,000 to $225,000. Compensation varies based on specific skills, experience, and education, alongside a comprehensive package that includes benefits, stock options, and an annual target bonus.

At Septerna, the work environment is dynamic and highly collaborative, aimed at fostering innovation and diversity of thought. Employees are encouraged to bring their authentic selves to work and contribute creatively towards the shared mission of developing life-changing therapies. You'll be surrounded by a motivated team of experts passionate about making a difference for patients.

In responding to this question, highlight specific projects where you successfully developed formulations for small molecules. Discuss challenges faced, how you optimized processes, and your familiarity with techniques such as amorphous solid dispersions or scale-up processes. Employer interest often lies in your ability to deliver effective formulations while meeting regulatory expectations.

For this question, provide examples of your project management skills tailored to the pharmaceutical development landscape. Talk about how you've utilized tools and strategies for prioritizing tasks, effectively managing time, and ensuring that critical milestones are met while balancing competing demands.

Discuss your understanding and application of regulatory guidelines such as ICH, FDA, and EMA in your previous roles. Highlight specific instances where you developed CMC strategies that adhered to these regulations, and explain how you ensure quality and data integrity in all phases of development.

In your answer, emphasize how you've managed relationships with CDMOs in your past roles. Share experiences involving selection, oversight, troubleshooting, and successful technology transfers. Mention how your collaborations led to meeting supply goals and regulatory submissions.

Provide a thoughtful analysis showcasing your awareness of current trends and challenges in the industry, like rapid technological advancements or regulatory hurdles. Discuss how you have navigated these challenges in your work and suggest innovative solutions or strategies you've found effective.

Address your commitment to continuous learning. Mention resources like industry publications, professional organizations, and networking opportunities. Share how you apply new insights and changes in regulatory expectations to enhance project execution and compliance.

Use the STAR method to structure your response — discuss the Situation, Task, Action, and Result. Make it relevant to pharmaceutical development and detail your problem-solving skills and decision-making process during that critical time.

Emphasize the importance of communication, mutual respect, and leveraging diverse expertise among team members. Share examples of how effective collaboration has been key in your past projects and how it leads to successful outcomes in drug development.

Highlight specific analytical techniques you've mastered, such as UPLC/HPLC and solid-state characterization. Discuss how these skills have enabled you to make informed decisions and provide data-driven insights throughout the development process.

Connect your answer to your passion for drug discovery and improving patient outcomes. Reflect on moments that energized you in your career, such as overcoming challenges, fostering innovative therapies, or collaborating with a talented team on transformative projects.