Senior Scientist/Principal Scientist

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!

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