Director, DMPK

Assembly Biosciences, Inc.•South San Francisco, CA

1d•Onsite

About The Position

We are seeking an experienced, creative, and highly motivated expert with industry research experience in DMPK focused on small molecule lead optimization for discovery research programs, preclinical and drug development. In addition to overseeing a group of external professionals, this position will be responsible for leading DMPK interactions with medicinal chemists to facilitate the identification of molecules meeting criteria for clinical development and support preclinical and clinical development. Specific responsibilities include, but are not limited to : Supervising a group of external DMPK scientists supporting research and development programs. Providing scientific guidance on chemical lead optimization programs and work in close collaboration with medicinal chemists to optimize the DMPK properties of candidate drugs. Closely interacting and effectively communicating with individual research and development groups. Ensuring complete preclinical DMPK assessment for clinical-stage candidate molecules. Understanding routes of elimination, levels and identity of circulating metabolites and toxicology coverage as needed. Supporting CTA and IND filings and contribute to clinical development for clinical candidates. Performing PKPD modeling for discovery and development projects. Scientific/technical aspects as well as management of assigned studies including protocol development, budget, timelines, oversight of outsourced activities, data analysis/interpretation and report writing. This job description outlines the primary duties and responsibilities of the role; however, it is not intended to be all-inclusive. The scope of responsibilities may be modified, expanded, or adjusted at the discretion of the organization to meet evolving business needs.

Requirements

PhD in chemistry, biochemistry, or related discipline, with 10+ years of pharmaceutical industry experience. In lieu of a PhD, candidates who possess a Bachelor’s or Master’s degree with additional industry experience will be considered
A strong background in ADME and pharmacokinetics/pharmacodynamics as applied in small molecule lead optimization.
Exceptional knowledge of metabolic routes of biotransformation, metabolite identification and the chemistry of drug metabolism are required.
The candidate should have demonstrated technical knowledge and industrial experience in multiple DMPK areas and an in depth understanding of the experimental DMPK methodologies and approaches, in vitro and in vivo, utilized in chemical lead optimization.
The candidate must be able to work with multiple disciplines in drug discovery and provide exceptional guidance to medicinal chemists in the lead optimization process.
The candidate needs the ability to conduct innovative research in DMPK applied to the discovery of novel drug candidates to achieve defined milestones in a fast-paced environment.
The candidate should have extensive knowledge of preclinical drug development and may have experience in the preparation of regulatory documents, e.g. INDs and NDAs.
The candidate should be goal oriented.
Highly effective organizational and communication skills.
The candidate should be self-motivated, with a track record of productivity, demonstrated leadership potential, possess effective interpersonal skills and be team oriented.

Nice To Haves

Experience and knowledge in Clinical Pharmacology.

Responsibilities

Supervising a group of external DMPK scientists supporting research and development programs.
Providing scientific guidance on chemical lead optimization programs and work in close collaboration with medicinal chemists to optimize the DMPK properties of candidate drugs.
Closely interacting and effectively communicating with individual research and development groups.
Ensuring complete preclinical DMPK assessment for clinical-stage candidate molecules.
Understanding routes of elimination, levels and identity of circulating metabolites and toxicology coverage as needed.
Supporting CTA and IND filings and contribute to clinical development for clinical candidates.
Performing PKPD modeling for discovery and development projects.
Scientific/technical aspects as well as management of assigned studies including protocol development, budget, timelines, oversight of outsourced activities, data analysis/interpretation and report writing.