*Note: exact level depending on experience*

Job Summary:

We are seeking a very highly motivated, collaborative biotransformation expert who is passionate and dedicated to using DMPK expertise to drive drug discovery and development programs at Vividion. The Biotransformation position will be responsible for all aspects of metabolite profiling, identification and associated enzymology of select projects. This position will be part of the Biotransformation group and will provide the opportunity to take on additional Biotransformation responsibilities for the broader Vividion portfolio.

This position has both technical and broader scientific advisory aspects including providing scientific and strategic input, guiding medicinal chemists in chemical series optimization, problem-solving and cross-functional collaboration, and innovation in a team environment. The successful candidate will design, execute, and manage in vitro soft-spot and tox species selection MetID studies, and definitive in vivo MetID studies. This role involves both experimental laboratory-based work and management of biotransformation studies conducted at CRO's. The successful candidate is expected to be well-versed in the interpretation of mass spectra, and proficient in the preparation of data summaries, presentation of results to project teams and management, authoring regulatory reports, and contributing to regulatory documents to support clinical development.

Requirements

Essential Duties and Responsibilities:

• Design and conduct non-labeled and radiolabeled in vitro and in vivo biotransformation studies supporting drug discovery and development
• Execute in vitro soft-spot and tox species selection MetID studies and conduct in vivo MetID studies
• Manage and provide oversight for biotransformation studies conducted at CRO's
• Interact with multidisciplinary project teams
• Lead DMPK studies supporting preclinical and clinical development
• Work collaboratively across functions to optimize drug candidates and understand species differences across metabolite profiles in support of toxicology studies
• Author reports, prepare data summaries and communicate results to project teams and management
• Author regulatory submission documentation including IND summaries and Investigator Brochure
• Mentor and motivate the in-house DMPK team

Education and Experience requirements:

• PhD in Organic Chemistry, Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, or related discipline with 7+ years of industry experience; MS/BS with 12+ years' experience will also be considered
• Expertise in drug metabolism, in vitro enzyme kinetics, ADME assays and LC/MS bioanalytical methodology
• Experience in working with radioactivity (3H and 14C) will be a bonus
• Experience in designing, executing and reviewing biotransformation studies
• Understanding of regulatory guidance as it pertains to biotransformation including MIST
• Experience in biotransformation document preparation for regulatory submissions is a plus

Core Competencies:

• Excellent written and verbal technical communication skills
• Ability to lead, guide, and influence teams in decision-making
• Collaborative team behaviors and ability to build and sustain relationships across internal scientific functions and the wider scientific community
• Ability to work autonomously and collaboratively in a multidisciplinary team setting
• Passion for data-driven analysis and strong business-of-science thinking
• Ability to thrive in a fast-paced, highly matrixed environment
• Strong understanding of DMPK, biotransformation, enzymology and DDI prediction strategies
• Proven track record of leading studies to enable IND filing and contributions to drug discovery
• Proficiency in managing CROs and robust knowledge of relevant regulatory guidance

Pay & Benefits:

The anticipated base salary for this position ranges from $150,000 to $220,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance.