NBE DMPK Lead (all genders), limited for 2 years

优缺点分析

角色解读

• This role offers the opportunity to become a recognized scientific leader in DMPK for novel biologics, with potential to move into broader scientific leadership positions within pharmaceutical R&D.
• Given the two-year limited term, this can serve as a stepping stone for senior roles in other biotech/pharma companies or a permanent position within Merck, leveraging the extensive network and experience gained.
• With increasing focus on AI/ML in drug development, you can further develop expertise in this frontier area, positioning yourself for future roles in computational drug discovery.
• You will serve as the scientific expert for DMPK across a portfolio of novel biological entities, defining the DMPK strategy for each molecule and integrating PK, immunogenicity, and bioanalytical approaches.
• You will apply modeling and simulation to generate data-driven insights, informing molecular design and translating preclinical findings into human dose predictions.
• You will guide peers and senior stakeholders in cross-functional project teams, shaping the scientific direction of projects and ensuring regulatory requirements are met for biotherapeutics.
• You will work on next-generation biotherapeutics such as ADCs, AOCs, and multispecific biologics, contributing to early and late-stage drug development.
• Deep expertise in pharmacokinetics and PK/PD concepts, including translational sciences and regulatory requirements for biotherapeutics like ADCs and multispecifics.
• Hands-on experience with quantitative modeling tools (e.g., population PK software, QSP platforms) and programming languages such as Python or R.
• Strong understanding of adjacent disciplines including pharmacology, toxicology, nonclinical safety, drug design, and bioanalytics.
• Excellent communication skills to convey complex scientific concepts to diverse audiences and influence decisions without direct authority.

申请策略

• Tailor your application to explicitly connect your experience with the biotherapeutics portfolio (ADCs, AOCs, multispecifics) and the DMPK challenges they present.
• Since the role is based in Germany, be prepared to discuss your willingness to relocate and your intercultural working experience.
• Highlight your track record in DMPK for biological entities, especially ADCs or multispecifics, with specific examples of strategy development and regulatory submissions.
• Showcase your quantitative modeling experience, including the tools and programming languages (Python/R, QSP, etc.) used to generate impactful insights.
• Demonstrate your ability to influence cross-functional teams, provide scientific guidance, and communicate complex ideas to senior stakeholders.
• Mention any experience with AI/ML applications in drug development, as this is a strong advantage.
• If you are not yet familiar with QC and regulatory expectations for biotherapeutics, review relevant FDA/EMA guidelines for ADCs and multispecifics.
• Enhance your proficiency in Python or R for PK/PD modeling, particularly using packages like NONMEM, Monolix, or QSP toolkits.

面试指南

• Use the STAR method (Situation, Task, Action, Result) to structure your answers, focusing on the impact of your contributions.
• Emphasize the integration of multiple disciplines (e.g., pharmacology, bioanalytics) in your decision-making, and show how you prioritize patient and regulatory needs.
• When discussing technical topics, explain the "why" behind your approach and the value it brings to the project, rather than just the methods.
• How would you design a DMPK strategy for a novel ADC molecule from discovery to first-in-human?
• Describe a time when you used modeling and simulation to influence a key drug development decision.
• How do you stay current with regulatory expectations for biotherapeutics, and can you provide an example of how you applied them?
• How do you communicate complex PK/PD concepts to non-experts in a cross-functional team?
• What experience do you have with AI/ML in drug development, and how might you apply it to DMPK?