Careers

VP of Clinical & Nonclinical Pharmacology

Garden City, NY or Remote

Job Summary

The VP, Clinical Pharmacology will be responsible for developing, driving, and implementing (with internal collaborations and working with consultants/external partners) global Clinical Pharmacology strategies across multiple indications. You will be a core member of the program team providing Clinical Pharmacology perspectives and delivering modeling and analyses necessary to evaluate clinical options, enable plans, and optimize development programs. This includes gap analysis, study design, PKPD analysis and modeling, program assessment, and internal collaborations to help execute programs. The successful candidate will bring extensive experience in clinical pharmacology and work cross-functionally with research and clinical teams to drive programs to success.

Accountabilities

  • Provide expertise for the design of pre-clinical and clinical studies
  • Ensuring/performing appropriate PKPD analysis including population PK, PKPD modeling and simulation, meta-analysis, and disease modeling as required by the program to aid in dose selection, trial design, and/or program decision-making.
  • Design, implement, drive, and monitor Clinical Pharmacology strategies.
  • Work with internal teams and external partners to execute program team objectives
  • Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures.
  • Leads the resolution of clinical pharmacology queries from regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
  • Analysis of PK data Directs the planning of all relevant PK-PD analyses.
  • Use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical trials in collaboration with translational science and statistics (as relevant).
  • Full knowledge about the clinical pharmacology profile of NO on which studies are being conducted or which are called for in the protocol.
  • Ensuring that there are valid methods for measuring concentration (and any biochemical biomarkers) in the R&D lab.

Activities

  • Participate in implementing model-based device development using quantitative approaches to address complex question arising during development spanning from target validation to analysis and interpretation of results.
  • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and development teams and in regulatory documentation.
  • Develop and execute modeling and simulation plans when appropriate; use model-based approaches to improve the efficiency of drug development and support dose selection and optimization when appropriate.
  • Serve as in-house expert on scientific matters
  • Discuss pharmacology, pharmacokinetics and toxicology issues with regulatory authorities in order to convey key concepts and facilitate understanding of both risks and results.
  • Contribute to program strategy, protocol preparation, study execution, data review/analysis, study reports, and regulatory document preparation; write and review clinical pharmacology summary documents.
  • Oversee vendors and consultants as appropriate.
  • May act as clinician for Phase I studies or clinical lead / research project lead for specific NO development projects.

Requirements

  • PhD in Pharmaconkinetics or Pharmaceutical Sciences or related field
  • Minimum 10 years of experience in biopharma industry in a Clinical Pharmacology role
  • Proven ability to represent Clinical Pharmacology on project teams
  • Experience with FDA regulatory interactions
  • Experience partnering with DMPK and translational science colleagues to ensure relevant clinical pharmacology strategy is developed.
  • Experience working cross-functionally and working with external partners.
  • Strong knowledge of the role of clinical pharmacology in medical device company, including the application of translational pharmacology as well as model-based approaches.
  • Ability to perform in fast-paced, dynamic, constantly evolving environment.
  • Excellent communication and organizational skills and attention to detail.
  • Strong time management skills; ability to prioritize multiple tasks efficiently.
  • Work outside the normal office hours as required

Reports to

SVP, Clinical Operations & Biometrics

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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