Title: Associate Director, Clinical Pharmacology
Location: Waltham, MA
Entasis is a leader in the use of PK/PD and translational pharmacology in support of anti-infective research and development. We have an open Associate Director position for an individual who would serve as a Clinical Pharmacology Lead in support of its late stage portfolio. The candidate would spearhead efforts in the utilization of mechanistic PK/PD models, population PK, and exposure response analyses to support critical development team decisions. In addition to being an integral member of clinical operation teams, the candidate would work in close collaboration with discipline leads to ensure a seamless transition of early discovery programs into clinical development. Key responsibilities include the performance of tasks involved with clinical pharmacology components of clinical projects including modeling and simulation, protocol preparation, clinical phase oversight, and reporting.
- Serve as the Clinical Pharmacology lead and point of contact on clinical sub teams
- Champion the use of quantitative translational pharmacology and PK/PD modeling to support the design and execution of a clinical development plan
- Responsible for providing the clinical pharmacology expertise, oversight and editing of components of clinical protocols, briefing documents, and regulatory submissions
- Coordinates with team members in the data review, analysis and reporting of clinical pharmacology sections of CSRs including PK and pharmacometrics analyses. Responsible for overall content and accuracy of study report, TFLs, etc. before forwarding for final sign-off.
- Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK/PD analysis including population PK, PK/PD modeling and simulation, and meta-analysis is provided where needed.
- Directs the planning of all relevant PK/PD analyses and coordinates directly with modeler/programmer with regard to analysis requirements and timeline expectations.
- Provides recommendations for clinical dose and regimen selection throughout all clinical trial stages of each program. Understands study requirements for evaluation of food effects, bioequivalence, renal and hepatic impairment and generation of data for Phase 2/3 dose justification.
- Contributes clinical pharmacology sections to all regulatory documents including Investigator Brochures, INDs, Scientific Briefing documents, and participation at EOP2 meetings. Addresses clinical pharmacology queries from drug regulatory agencies and takes a lead role in writing and reviewing responses to regulatory queries. Knowledgeable of Guidance for Industry publications and applying concepts to job tasks.
- Works with DMPK VP to ensure translation of pre-clinical data to support clinical pharmacology objectives for clinical trial design, initiation, and completion. Works with Discovery teams to develop a quantitative mechanistic understanding of PK/PD for each program to support projection of a safe and efficacious clinical dose.
- Supports and provides oversight of bioanalytical assay validation/sample bioanalysis within all clinical trials.
- Strong quantitative skills and expertise (e.g. experience in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations)
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or another suitable post-graduate qualification
- 3-5 years of industry experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
- Excellent written and verbal communication skills
- Demonstrated presentation skills and ability to influence and collaborate with peers.