Vice President, Clinical Pharmacology and DMPK

The Vice President of Clinical Pharmacology and DMPK at Septerna is primarily responsible for leading the clinical pharmacology strategy and overseeing clinical pharmacology activities within the organization. This role involves managing group deliverables, ensuring alignment with strategic business objectives, and collaborating with other functional leaders to drive organizational success.

Candidates applying for the Vice President of Clinical Pharmacology and DMPK at Septerna should possess a PhD, PharmD, or equivalent degree in pharmaceutical sciences, pharmacology, or a related field. Additionally, a minimum of seventeen years of experience in the Biotech or Pharma industry is required, including expertise in applied Population PK, PK/PD, and exposure-response modeling.

The anticipated salary range for the Vice President of Clinical Pharmacology and DMPK position at Septerna, based in South San Francisco, CA, is between $320,000 and $350,000. Compensation may vary based on factors like job-related skills, experience, work location, and relevant education.

The Vice President of Clinical Pharmacology and DMPK at Septerna will oversee all clinical pharmacology activities, manage budgets related to PK and PK/PD analyses, coordinate processes for bioanalytics, and ensure timely execution of key deliverables. This role is pivotal in ensuring that clinical pharmacological strategies align with regulatory requirements for safety and efficacy.

Septerna actively embraces diversity of thought, expertise, and background within its teams. As the Vice President of Clinical Pharmacology and DMPK, you will find an environment that fosters collaboration, encourages open dialogue, and values diverse perspectives to help create innovative solutions in drug development.

When answering this question, highlight your passion for drug development and your alignment with Septerna's mission of creating therapeutics for unmet medical needs. Discuss how your previous experiences have prepared you for this role and your excitement about the opportunity to contribute to a collaborative and innovative environment.

Detail your specific experience with IND enabling studies, emphasizing key projects you've led or contributed to. Highlight your understanding of regulatory requirements and how your expertise can enhance the clinical pharmacology strategies at Septerna.

Discuss your leadership philosophy, including mentorship and development strategies. Provide examples of how you've successfully built high-performing teams, focusing on collaboration, diversity, and achieving strategic goals.

Explain your project management approach, emphasizing prioritization, cross-functional collaboration, and effective communication. Highlight any tools or methodologies you've used to streamline processes and ensure deadlines are met.

Articulate the importance of these models in optimizing drug dosing, understanding efficacy, and regulatory compliance. Share specific examples where you implemented these models successfully in your previous roles and the outcomes that followed.

When responding, demonstrate your knowledge of FDA guidelines and how they influence clinical pharmacology practices. Share any direct experiences you've had during drug submissions and regulatory interactions.

Provide a narrative of a clinical trial where you played a crucial role, detailing your responsibilities, challenges faced, and how your leadership contributed to the project's success. Highlight data-driven decision-making and collaboration with various functional teams.

Address current issues such as data management, regulatory hurdles, and the need for innovative modeling approaches. Discuss how your background and insights prepare you to tackle these challenges at Septerna.

Discuss the methods you use to keep abreast of the latest research and industry developments, such as attending conferences, engaging with professional networks, and reading relevant journals.

Encourage candidates to express their curiosity about the company's culture, team dynamics, and future therapeutic focuses. This dialogue can provide insights into the company values and how they align with the candidate's aspirations.