Associate Director, Clinical Pharmacology

Job Locations US-PA-Wayne
Posted Date 2 months ago(4/29/2021 6:37 PM)
Job ID
2021-1348
# of Openings
1
Category
Research & Development

Overview

Position Summary: 

 

The Associate Director, Clinical Pharmacology position reports to the Director, Non-Clinical Development  R&D having the following responsibilities.

The candidate will be working primarily to support development projects in Immuno-inflammatory/Oncology diseases, including the design, implementation, and reporting of clinical pharmacology studies (DDI, TQT, hepatic/renal insufficiency, BA/BE, etc.) based on applicable regulatory requirements. These activities include establishing PK/PD clinical plans, performing PK/PD analysis, authoring clinical pharmacology sections of clinical study reports (CSR) and all applicable worldwide regulatory documents (IB, IND, NDA, MAA, etc.). The candidate will be responsible for designing/planning/monitoring/reporting of Clinical Pharmacology studies in collaboration with Clinical Research and Nonclinical Drug Development.

The candidate will possess a significant understanding of clinical PK and PK/PD concepts and applications as well as have knowledge of drug metabolism, physiology, and human and animal studies for drug development programs.

This position will work closely with clinical, nonclinical, regulatory, and project management and advise project teams and management on the clinical pharmacology programs for all development projects and take part in communicating study design and results with domestic and foreign regulatory agencies.

Responsibilities

Essential Duties and Responsibilities:

 

  • Responsible for the development and execution of the overall Clinical Pharmacology strategy and data interpretation of Clinical Pharmacology studies in support of drug candidates.
  • Responsible for the development and execution of the pharmacometrics plan in support of clinical development projects and managing external vendors sourced for conducting pharmacometric analyses (eg, population PK and PK/PD analyses, physiologically-based PK analysis, etc.).
  • Responsible for providing input (from a PK perspective) into clinical study protocols and reports and for preparation of the Clinical Pharmacology sections of regulatory documents (eg, IB, IND, NDA, etc.).
  • Responsible for managing the operational elements of Clinical Pharmacology studies.
  • Responsible for representing the Clinical Pharmacology function both internally (study and project teams) and externally (meetings with regulatory authorities, collaborators, external vendors).
  • Secondary responsibilities (as time permits) will also include supporting development projects from a nonclinical DMPK perspective.

Work Conditions:

  • This job operates in a professional office environment.
  • This role routinely uses standard office equipment such as computers, phones, and photocopiers.
  • This position is required to work occasional nights and weekends to meet company demands. 

Physical Demands:

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 

While performing the duties of this job, the employee is occasionally required to stand, walk, use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms.  The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear. 

 

The employee must occasionally lift and/or move objects up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. 

Qualifications

Required Education and Experience:

 

  • PhD in Pharmaceutical Sciences, Biopharmaceutics, Clinical Pharmacology, or other relevant life sciences and at least 5 years of industry experience in clinical pharmacology.
  • Experience in clinical research and working within a clinical study team.
  • Experience in PK analysis using standard methodologies (eg, NCA and compartmental analysis using Phoenix WinNonlin) and more advanced modeling/simulation methodologies (eg, population PK and PK/PD analyses using NONMEM, PBPK using GastroPlus).
  • Strong understanding of the overall drug development process both from a nonclinical and clinical perspective.
  • Strong oral and written communication skills, and ability to effectively manage CRO’s and external vendors for clinical and nonclinical DMPK drug development studies.
  • Ability to interpret PK and PK/PD results and prepare presentations to accurately and effectively communicate study results to project teams, management, and regulatory authorities.
  • Thorough understanding of regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines relevant to the conduct of clinical pharmacology studies (eg, drug-drug interaction, bioavailability/bioequivalence, special populations, etc.).
  • Assists department head, as needed, with budgetary planning, including capital equipment procurement.
  • Strong problem solver who has the ability to work in an environment with rapidly changing priorities and aggressive drug development timelines.

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