Senior Director DMPK
This is a clinical-stage biotechnology company advancing two innovative platform programs: a Hepatitis B-Cure program consisting of a new class of oral therapeutic candidates for the treatment of hepatitis B virus (HBV) infection and a novel class of oral synthetic live biotherapeutic candidates, which are designed to treat disorders associated with the Microbiome.
The HBV pipeline consists of a lead program in multiple global Phase 2a studies; a 2nd Generation program entering Phase I late this year, and a 3rd program approaching clinical candidate selection. We expect this pipeline to represent a backbone therapy for increasing cures in HBV, and can be envisioned as a foundation of the company’s research in virology globally.
The Microbiome platform consists of our lead programs in GI, partnered with Allergan, nearing the first IND/Phase Ib later this year and early next for Ulcerative Colitis, and a pipeline of other disease areas in consideration for advancement that are wholly owned by ASMB.
The Company has a strong balance sheet having recently raised $166 million, bringing its cash reserves to approximately $250 million – and thus positioned well to build the next phase of the company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
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 clinical 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 successful achievement of lead optimization programs and the rapid and efficient progression of drug candidates in preclinical development.
Specific responsibilities include, but are not limited to:
- Direct and orchestrate external DMPK scientists supporting multiple drug discovery and early development programs
- Provide scientific guidance on chemical lead optimization programs and work in close collaboration with medicinal chemists to optimize and characterize the DMPK properties of candidate drugs
- Provide preclinical support and evaluation of drug candidates in development programs
- Close interaction with individual research and development groups, and effective communication with peers and with the company R&D leadership
- The candidate should have a PhD or equivalent degree in chemistry, biochemistry or related discipline, a minimum of 5 years of pharmaceutical industry experience and 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 in the preparation of DMPK sections of regulatory documents, e.g. INDs and NDAs.
- The candidate should be a goal-oriented and effective leader. Additional requirements include effective mentoring of scientific staff and highly effective organizational and communication skills
- The candidate should be self-motivated, attentive to detail, with fast response times, a track record of productivity, possess effective interpersonal skills and be team oriented
- The preferred candidate would also have experience and knowledge in the CMC arena and drug formulation