In this role, you will:
- Lead Metabolite Profiling: Oversee the identification and characterization of metabolites and conduct enzymology studies.
- Drive Innovation: Provide scientific and strategic input to guide medicinal chemists in optimizing chemical series and solving complex problems.
- Collaborate Cross-Functionally: Work closely with team members to ensure innovative solutions and successful project outcomes.
- Design and Manage Studies: Plan and execute in vitro soft-spot and tox species selection MetID studies and definitive in vivo MetID studies.
- Execute Experimental Work: Perform laboratory experiments and manage biotransformation studies conducted at CROs.
- Analyze and Present Data: Interpret mass spectra, prepare data summaries, and present findings to project teams and management.
- Contribute to Regulatory Documentation: Author and support regulatory reports and documents to facilitate clinical development.
Requirements:
- Education & Experience: PhD in Organic Chemistry, Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline with 7+ years of industry experience; alternatively, MS/BS with 12+ years of relevant experience.
- Expertise: Extensive knowledge in drug metabolism, in vitro enzyme kinetics, ADME assays, and LC/MS bioanalytical methodologies.
- Biotransformation Studies: Proven experience in designing, executing, and reviewing biotransformation studies.
- Regulatory Knowledge: Understanding regulatory guidance related to biotransformation, including MIST, with experience in preparing biotransformation documents for regulatory submissions is considered a plus.
Core Competencies:
- Communication Skills: Exceptional written and verbal technical communication abilities.
- Leadership & Influence: Proven ability to lead, guide, and influence teams in decision-making processes.
- Collaboration: Strong collaborative skills with the ability to build and maintain relationships across internal scientific functions and the broader scientific community.
- Autonomy & Teamwork: Capability to work independently and collaboratively within a multidisciplinary team setting.
- Data-Driven Analysis: Passion for data-driven analysis with a solid understanding of business-of-science thinking.
- Adaptability: Ability to excel in a fast-paced, highly matrixed environment.
- Technical Expertise: Deep knowledge of DMPK, biotransformation, enzymology, and DDI prediction strategies.
- Track Record: Demonstrated success in leading studies that support IND filings and contribute to drug discovery.
- CRO Management: Proficiency in managing CROs and a strong grasp of relevant regulatory guidance.
The ideal candidate will have strong expertise in mass spectrometry, experience with regulatory submissions, and a proven track record of working effectively in a team environment.
If you are a highly motivated individual with a passion for DMPK and drug development, apply today to join our innovative team!
