Director, Clinical Pharmacology at VenatoRx Pharmaceuticals
Malvern, PA, US

Venatorx Pharmaceuticals is a private pharmaceutical company focused on the discovery and development of novel anti-infectives to treat multi-drug-resistant (MDR) bacterial infections and hard-to-treat viral infections. We have proudly built a world-class, in-house drug R&D organization in Malvern, PA with over 70 employees.

Our most advanced development-stage product is taniborbactam (formerly VNRX-5133), an injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro activity against both serine- and metallo-beta-lactamases (MBLs), including ESBL, OXA, KPC, NDM, and VIM enzymes. Venatorx initiated enrollment in its Phase 3 trial of cefepime-taniborbactam in patients with complicated urinary tract infections (cUTIs) in August 2019 and top-line results are expected by the end of 2020. Our second development-stage product in clinical development is VNRX-7145, an orally bioavailable BLI that in a fixed combination with the third generation orally bioavailable cephalosporin, ceftibuten, has the potential to rescue activity of the partner antibiotic against ESBLs and key carbapenem-resistant Enterobacteriaceae, including those expressing KPC and OXA carbapenemases.

Additionally, we have a broad pipeline of preclinical programs including a novel class of Penicillin-Binding Protein (PBP) inhibitors that are impervious to beta-lactamase-driven resistance, and novel antiviral agents targeting Hepatitis B Virus. All Venatorx investigational molecules were discovered internally and our scientists have filed over 100 patents spanning multiple research programs.

Venatorx has received significant funding awards from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH); Wellcome Trust; the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Service (HHS); the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA); and CARB-X, and as well as private equity investments from Versant Ventures, Abingworth and Foresite Capital.

The Director, Clinical Pharmacology is a highly scientific strategic role leading multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. This individual will be responsible for developing and implementing the clinical pharmacology strategy for Venatorx’s product portfolio, including design and execution of clinical pharmacology studies, data analysis, internal decision making, and external regulatory interactions.

Responsibilities include:

    Develop and implement pharmacokinetic, pharmacodynamic, drug interaction studies to support overall development and regulatory submissions including marketing approval
    Work closely with cross functional teams, including Nonclinical Safety and Toxicology as well as Clinical Development and Medical Sciences, and be the subject matter expert in pharmacology, pharmacokinetics and pharmacodynamics in order to support dose selection for early clinical trials
    Provide input and oversight to pharmacokinetic and pharmacodynamic modeling required to support development and approval of antibiotics, including extrapolation into patient subsets
    Lead the development of bioanalytical methods and qualification, usually in conjunction with external experts and qualified CROs, and the internal team.
    Author components and review overall program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
    Represent clinical pharmacology during meetings and discussions with regulatory authorities
    Maintain a high standard for good laboratory and clinical practices, compliance, and ethical standards
    Support non-clinical pharmacology efforts when appropriate

Successful candidates will demonstrate:

    PhD in pharmaceutical sciences/pharmacology/related field or MD or PharmD with at least 7 years of relevant clinical pharmacology experience within the pharmaceutical and biotechnology industry
    Prior experience with small molecules is preferred
    Experience filing INDs and supporting NDAs/BLAS required
    Demonstrated experience in writing, presenting, and discussing clinical pharmacology with both internal and external stakeholders, including regulatory authorities
    Strong analytical skills and ability to interpret complex nonclinical and clinical data sets coupled with excellent written and verbal communication skills
    Proven ability to work in cross-functional teams and manage multiple projects, engaging subject matter experts across functions to drive the execution of programs
    Ability to thrive in a fast-paced and evolving company environment
    Proven ability to work with a high level of integrity, accuracy, and attention to detail
    Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions
    Ability to operate autonomously in a fast-paced early phase company

Equal Employment Opportunity/M/F/disability/protected veteran status